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Introduction | myopia, Myopia | MYOPIA, EYE DISEASES, MYOPIA | Myopia is one of the most common eye diseases and is of worldwide concern.Currently, several interventions have been proposed to prevent the onset of myopia, such as increased outdoor time,Repeated low-level red-light (RLRL) therapy delivered by a device emitting 650-nm visible red light has been proposed as an alternative myopia control intervention. | PMC10134010 |
Methods | This 12-month, 2-group, single-blinded, school-based randomized clinical trial was conducted in Shanghai, China. Children from 10 primary schools were enrolled between April 1, 2021, and June 30, 2021. Examinations were conducted at baseline and at the 3-, 6-, 9-, and 12-month follow-up visits. This trial was completed August 31, 2022. The study was approved by the Shanghai General Hospital Ethics Committee and adhered to the tenets of the Declaration of Helsinki. | PMC10134010 | ||
Eligibility Criteria | astigmatism, strabismus, ocular abnormalities, anisometropia | SYSTEMIC DISEASE, ASTIGMATISM, STRABISMUS, MYOPIA, -11, ANISOMETROPIA | Eligible participants were primary school students in grades 1 to 4 (aged 6-11 years) with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of −0.50 to 0.50 (inclusive) diopters (D) and having at least 1 parent with an SER in either eye of −3.00 D or less. Children were excluded if they had astigmatism of 1.50 D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions. | PMC10134010 |
Randomization and Masking | The randomization was stratified by grade and allocated to individuals at a ratio of 1:1. The randomization list was generated using R software, version 3.6 (R Group for Statistical Computing). To avoid stigmatization for being selected or not, children, parents, and teachers were educated on the purpose of the study and randomization. They were also informed of the right to withdraw at any time. Children and their guardians were aware of the study allocation due to the nature of the intervention. Outcome assessors and statisticians were masked. | PMC10134010 | ||
Intervention | Children in the intervention group received the RLRL intervention, while those in the control group did not. The RLRL intervention was provided by a desktop device (Eyerising, Suzhou Xuanjia Optoelectronics Technology; eFigure 1 in | PMC10134010 | ||
Intervention Compliance Monitoring | During semesters, children in the intervention group completed treatment at school. During summer and winter vacations, guardians were trained by teachers to supervise the intervention at home. The device was linked to the internet with an automated diary function to record the treatment history. In addition, 2 investigators (X.H. and J.W.) were responsible for the intervention compliance management. School teachers or parents or legal guardians were reminded about the intervention to improve treatment compliance every week. | PMC10134010 | ||
Data Collection | Diabetic Retinopathy | CYCLOPLEGIA, CYCLOPLEGIA, DIABETIC RETINOPATHY | Clinical examinations were performed at baseline and at 3-, 6-, 9-, and 12-month follow-up visits. Baseline demographic characteristics were collected via questionnaire; the information was obtained from school teachers with permission from the participants and their guardians.Uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) were assessed at 4 m by trained optometrists using the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart (Guangzhou Xieyi Weishikang). Axial length (AL) was measured before cycloplegia using the IOLMaster (Carl Zeiss Meditec) and averaged until the maximum error did not exceed 0.05 mm. Cycloplegia was induced half-yearly using 2 drops of 1% cyclopentolate (Alcon) 5 minutes apart. One additional drop was administered 5 minutes later if cycloplegia was insufficient. After an additional 30 minutes, full cycloplegia was present if the pupil diameter reached at least 6 mm and the pupillary reaction to light was absent. Refraction data were measured using an autorefractor (KR8800; Topcon) 3 times after cycloplegia and averaged until the desired precision (0.25 D) was achieved. Optical coherence tomography (OCT) scans and fundus images were obtained from swept-source OCT (DRI OCT Triton; Topcon) under radiographic scanning (radial 9 mm). Choroidal thickness was obtained automatically from the built-in segmentation software. | PMC10134010 |
Outcomes | myopic, myopia, choroidal thickness | MYOPIA, MYOPIA, SECONDARY | The primary outcome was the 12-month cumulative incidence of myopia in both groups. Myopia was defined as the cycloplegic SER (sphere plus half of cylinder) of −0.50 D or less in the more myopic eye. Secondary outcomes of the study were the changes in SER, AL, choroidal thickness, UCVA, and BCVA over 1 year. Data from the more myopic eye at baseline were also used for secondary outcomes analysis. | PMC10134010 |
Adverse Events | hemorrhage, atrophy | PROLIFERATION, MACULAR HOLE, HEMORRHAGE, ATROPHY | At baseline, all children in the intervention group completed 1 session of the RLRL intervention. The children were asked to close their eyes until the bright spot, also known as the Fundus images by swept-source OCT were independently evaluated by 2 accredited senior ophthalmologists. Any fundus abnormality and its grading, including but not limited to vitreomacular traction, macular schisis, macular hole, intraretinal fluid, subretinal fluid, hemorrhage, retinal pigment epithelium proliferation, and atrophy, would be recorded. Any difference between the 2 graders was adjudicated by a third senior ophthalmologist (X.X.). | PMC10134010 |
Sample Size | myopia | MYOPIA | The sample size estimation was conducted based on the assumption of a 2-sided α level of .05, 90% power, and the expected effect size. The incidence of myopia among primary school students with premyopia was approximately 42% per year, | PMC10134010 |
Statistical Analysis | Statistical analyses were performed using SAS, version 9.4 (SAS Institute Inc). Outcomes were analyzed by means of an intention-to-treat method and a per-protocol method. The intention-to-treat analysis included participants in both groups at baseline, while the per-protocol analysis included participants in the control group and those in the intervention group who were able to continue the intervention without interruption by the COVID-19 pandemic. A comparison between the 2 groups was performed using the χ | PMC10134010 | ||
Results | A total of 278 children (28.1%) were included in the trial: 139 children (mean [SD] age, 8.3 [1.1] years; 71 boys [51.1%]) in the intervention group and 139 children (mean [SD] age, 8.3 [1.1] years; 68 boys [48.9%]) in the control group ( | PMC10134010 | ||
Flowchart of the Study | MAY | Because of the COVID-19 pandemic and the associated sudden lockdown in Shanghai from March to May 2022, the number of participants at the 9-month visit and compliance with the treatment during the last 3 months in the intervention group were affected significantly when the children did not bring the devices home from school. A total of 65 of 139 children (46.8%) in the intervention group and 73 of 139 children (52.5%) in the control group did not attend the 9-month follow-up visit. For the last 3 months of the study, 32 of 139 children (23.0%) in the intervention group were able to continue the RLRL treatment. Despite this, we continued the trial and tried our best to complete the examination at the 12-month visit. Of 278 included children, 248 (89.2%) participated in the 12-month visit, consisting of 126 children (90.6%) in the intervention group and 122 children (87.8%) in the control group. The median compliance rate in the intervention group was 60.0% (IQR, 54.2%-64.8%). | PMC10134010 | |
Primary Outcome | MYOPIA | The 12-month incidence rate of myopia was 40.8% (49 of 120) in the intervention group and 61.3% (68 of 111) in the control group ( | PMC10134010 | |
Refractive and Biometric Outcomes at 12-Month Follow-up (Intention-to-Treat Analysis) | Abbreviations: AL, axial length; D, diopters; NA, not applicable; SER, spherical equivalent refraction.The intervention group included those who continued the intervention and those with interrupted intervention.Risk difference, absolute efficacy = value in control group − value in intervention group.Relative risk = value in intervention group/value in control group.Relative efficacy = (value in control group − value in intervention group)/value in control group.The | PMC10134010 | ||
Secondary Outcomes | For the intervention group, the mean (SD) SER change over 12 months was –0.35 (0.54) D. For the control group, the corresponding mean (SD) change was –0.76 (0.60) D. The absolute mean difference in SER change between the 2 groups was –0.41 D (95% CI, –0.56 to –0.26 D; The 12-month mean (SD) AL increase was 0.30 (0.27) mm for the intervention group and 0.47 (0.25) for the control group, with an absolute mean difference in AL changes of 0.17 mm (95% CI, 0.11-0.23 mm; | PMC10134010 | ||
Axial Length (AL) Change Between the Intervention and Control Groups Over 12 Months | hyperopic | REGRESSION | The proportions of children showing SER regression (hyperopic shift of >0.25 D, which cannot be explained as the measurement errors in refraction device) in the intervention group were 51.2% (62 of 121) at the 6-month follow-up visit and 19.0% (23 of 121) at the 12-month follow-up visit, while the corresponding proportions in the control group were 24.5% (25 of 102) at 6 months and 2.7% (3 of 111) at 12 months (eTable 3 in At the 12-month follow-up visit, the proportion of children whose UCVA decreased by at least 2 lines was significantly greater in the control group than in the intervention group (17.5% [22 of 126] vs 32.0% [39 of 122]; | PMC10134010 |
Vision Function and Choroidal Thickness at the 12-Month Follow-up (Intention-to-Treat Analysis) | choroidal thickness | Abbreviations: BCVA, best corrected visual acuity; CT, choroidal thickness; UCVA, uncorrected visual acuity.The intervention group included those who continued the intervention and those with interrupted intervention.The | PMC10134010 | |
Effect of the COVID-19 Pandemic | The baseline characteristics between the continued intervention group and the interrupted intervention group were well balanced (eTable 4 in | PMC10134010 | ||
Adverse Events | Two participants withdrew from the study because the afterimage duration exceeded 6 minutes at baseline. According to swept-source OCT images, no other structural damage was noted in the intervention and control groups. | PMC10134010 | ||
Sensitivity and Subgroup Analyses | MYOPIA | Subgroup analyses comparing the efficacy of intervention for myopia prevention and control (incidence, SER changes, and AL changes) by different baseline SER groups and age groups were performed. Better efficacy was observed among children with an SER of 0.01 to 0.50 D than among those with an SER of −0.50 to 0.00 D (relative efficacy, 64.0% vs 14.0%; SER changes, 69.0% vs 39.8%; AL changes, 45.7% vs 23.4%) ( | PMC10134010 | |
Refractive and Biometric Outcomes at 12-Month Follow-up in Different Baseline SER Groups (Adjusted for Baseline Age) | Abbreviations: AL, axial length; D, diopters; SER, spherical equivalent refraction.The intervention group included those who continued the intervention and those with interrupted intervention.Absolute efficacy = value in control group − value in intervention group; relative efficacy = (value in control group − value in intervention group)/value in control group.Difference of efficacy = the efficacy difference between 2 subgroups. | PMC10134010 | ||
Discussion | myopia | MYOPIA | To our knowledge, this was the first trial to date to investigate the efficacy of the RLRL intervention in myopia prevention. In this 12-month randomized clinical trial, the RLRL intervention achieved an absolute difference of 20.4% in incidence of myopia, representing a 33.4% relative reduction in incident myopia. For children without treatment interruption due to the COVID-19 pandemic, the absolute difference increased to 33.2%, representing a 54.1% relative reduction in incident myopia over 12 months. | PMC10134010 |
Effect of RLRL Intervention on Myopia Incidence | myopia | MYOPIA | The efficacy of a 33.4% to 54.1% relative reduction in the incidence of myopia with the RLRL intervention should be interpreted carefully. Increased outdoor time has been consistently shown to have an efficacy rate ranging from 11.0% to 54.3% in preventing myopia onset within 1 year. | PMC10134010 |
Effect of RLRL Intervention on Myopic Shift | myopic | MYOPIA | We found that the RLRL intervention significantly reduced the myopic shifts in terms of AL and SER compared with the control group (difference, 0.17 mm and –0.41 D, respectively). In the subgroup analysis of individuals with premyopia from a randomized clinical trial in Taiwan, a 1-year outdoor intervention achieved reductions of myopia shift by 0.04 mm for AL and 0.11 D for SER. | PMC10134010 |
Influencing Factors of RLRL Intervention Efficacy | MYOPIA, MYOPIA | Our results showed that the effect of the RLRL intervention on myopia prevention was different among baseline SER groups. The RLRL intervention was more effective among children with an SER of 0.01 to 0.50 D at baseline than those with an SER of −0.50 to 0.00 D at baseline. In 2021, the International Myopia Institute defined premyopia as a refractive state of an eye of +0.75 D or less and more than −0.50 D in children. | PMC10134010 | |
Safety | blindness | RETINA, BLINDNESS | After this 12-month RLRL intervention, no functional damage as indicated by BCVA was observed. No children reported having glare, flash blindness, or afterimages longer than 6 minutes after treatment. An afterimage induced by prior adaptation to a visual stimulus is believed to be due to bleaching of photochemical pigments or neural adaptation in the retina. Participants with an afterimage duration exceeding 6 minutes were clinically considered too sensitive to visual stimulus. | PMC10134010 |
Limitations | MYOPIA | This study had several limitations. First, the open-label design may bias the results. Future studies comparing a light treatment simulator with a much lower power should exclude potential placebo effects. Second, because of the outbreak of the COVID-19 pandemic in Shanghai, approximately 70% of the children in the intervention group discontinued treatment from 9 to 12 months. Nevertheless, we tried to maximize the follow-up retention rate for the 12-month visit. Furthermore, children who continued treatment and those who discontinued treatment were well balanced for baseline characteristics. Third, the observed efficacy of the intervention in preventing myopia was generalizable only to the device used in the present study. It is unproven that other wavelengths, power intensities, or frequencies of intervention may have a similar or even better efficacy. | PMC10134010 | |
Conclusions | myopia | MYOPIA | This randomized clinical trial found that RLRL is a novel and effective intervention for myopia prevention, with good user acceptability and a 54.1% reduction in incident myopia within 12 months for children with premyopia. Our findings have public health significance, especially for myopia prevention in countries with a high incidence of myopia. More studies are needed to understand the long-term efficacy and safety, optimal intervention dose, and potential underlying mechanisms of the RLRL intervention. | PMC10134010 |
1. Introduction | Depression, Anxiety | The use of electronic patient-reported outcomes has increased recently, and smartphones offer distinct advantages over other devices. However, previous systematic reviews have not investigated the reliability of the Center for Epidemiologic Studies Depression Scale (CES-D), Generalized Anxiety Disorder-7 (GAD-7), and Kessler Screening Scale for Psychological Distress (K6) when used with smartphones, and this has not been fully explored. This study aimed to evaluate the equivalence of the paper and smartphone versions of the CES-D, GAD-7, and K6, which were compared following a randomized crossover design method in 100 adults in Gunma, Japan. Participants responded to the paper and smartphone versions at 1-week intervals. The equivalence of paper and smartphone versions was evaluated using the intraclass correlation coefficient (ICCThe use of patient-reported outcomes (PROs) is neccessary because of several advantages [Compared with paper-based PROs, ePROs minimize errors in score calculation and data entry and missing data, facilitating reliable analysis and reporting of PRO data [Currently, many devices are being utilized for ePROs [ | PMC10049019 | |
2. Materials and Methods | PMC10049019 | |||
2.1. Study Design | This study was conducted using a randomized crossover design to assess the format equivalence of the paper and smartphone versions of the CES-D, GAD-7, and K6. | PMC10049019 | ||
2.2. Participants and Procedure | RECRUITMENT | The study participants were recruited between October 2022 and December 2022 from Gunma University in Gunma, Japan. The recruitment was made by posting posters at Gunma University. Study participation was also encouraged via e-mail and social networking services. Individuals aged ≥18 years who were native Japanese speakers and had a smartphone were considered eligible for this study. Participants who met the eligibility criteria were asked to complete the CES-D, GAD-7, and K6 scales (paper and smartphone versions) after answering demographic information (age and sex) and lifestyle characteristics (i.e., drinking, exercise, and smoking habits). The order in which the PROs were filled out (paper version first or smartphone version first) was randomly determined. To reduce potential recall and carryover effects, the interval between the completion of the two questionnaires was 1 week. | PMC10049019 | |
2.3. Randomization | Participants were randomly assigned in a 1:1 ratio to complete either the paper version first or the smartphone version first before answering the questionnaire (CES-D, GAD-7, and K6). The randomization list was generated by a permuted block method (block size 4) using a computer (Microsoft Excel) by a third party unrelated to the study. The randomization list was sent to the Central Registry Center at Kurashiki Heisei Hospital in Okayama Prefecture, Japan, for random assignment. | PMC10049019 | ||
2.4. Sample Size | The ISPOR guidelines report that 43 participants with no missing data are needed to declare an ICC of ≥0.7 at 80% power and 95% confidence level if the ICC observed in two measurements is expected to be 0.85, using the approximation used by Walter et al. [ | PMC10049019 | ||
2.5. Measures | PMC10049019 | |||
2.5.1. CES-D | depressive symptoms | The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms [ | PMC10049019 | |
2.5.2. GAD-7 | anxiety disorder | The GAD-7 is a 7-item self-report questionnaire used to measure generalized anxiety disorder, on a 0–3 Likert scale (0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day) [ | PMC10049019 | |
2.5.3. K6 | The K6 is a 6-item self-report questionnaire used to measure psychological distress, using a 0–4 Likert scale (0 = none of the time, 1 = a little of the time, 2 = some of the time, 3 = most of the time, and 4 = all of the time) [ | PMC10049019 | ||
2.6. Software | Electronic versions of CES-D, GAD-7, and K6 were provided on participants’ smartphones using Google Forms. The questionnaires were presented in the order CES-D, GAD-7, and K6. The questions, answer choices, and order of questions in the electronic version are the same as those in the paper version of the three scales. Each questionnaire was presented on a separate page; however, all the questions for each questionnaire are displayed on the screen. Scrolling down the screen allows the user to move to the next answer. After answering all the questions in the questionnaire, the next questionnaire can be answered by pressing the “Next” button (specifically, the 20 questions in the CES-D are displayed on a single page, and after answering all of them, the “Next” button is pressed to move to the GAD-7 questionnaire page). Participants can select their answers by tapping the radio buttons on the screen. It is not possible to move to the next page without answering a question item or to select two answers to the same question. However, it is possible to change a previous answer by pressing the “Back” button. | PMC10049019 | ||
2.7. Statistical Analysis | In this study, the switch from the paper version to the smartphone version corresponds to the light to moderate adjustment suggested by the ISPOR guidelines [ | PMC10049019 | ||
3. Results | PMC10049019 | |||
3.1. Characteristics of the Study Participants | Of the 100 participants who met eligibility, 100 completed the paper and smartphone versions of the questionnaire and provided complete data. In the paper-first group, 50 participants first completed a paper-version questionnaire. In the smartphone-first group, 50 participants first completed the smartphone version questionnaire. The mean age of the study participants was 19.86 years (SD = 1.08, 23% male), 9 (9%) had a drinking habit, 1 (1%) had a smoking habit, and 37 (37%) had an exercise habit ( | PMC10049019 | ||
3.2. Mean and LMM Results | The mean values for each group and the LMM results are shown in | PMC10049019 | ||
3.3. Equivalence | The ICC | PMC10049019 | ||
3.4. Internal Consistency | Cronbach’s alpha values for the CES-D score were 0.82 (95% CI 0.77–0.87) and 0.81 (95% CI 0.75–0.86) for the smartphone and paper versions, respectively. Cronbach’s alpha values for the GAD-7 score were 0.80 (95% CI 0.75–0.86) and 0.80 (95% CI 0.75–0.86) for the smartphone and paper versions, respectively. Cronbach’s alpha values for the K6 score were 0.88 (95% CI 0.84–0.92) and 0.82 (95% CI 0.77–0.88) for the smartphone and paper versions, respectively ( | PMC10049019 | ||
4. Discussion | This study evaluated the equivalence of the embodiments to the CES-D, GAD-7, and K6 evaluated in smartphone and paper versions. The results suggest that CES-D and K6 have good equivalence, with ICCThe Cronbach’s alpha for the GAD-7 on smartphones was 0.80 (95% CI 0.75–0.86), indicating that it has the same internal consistency as the GAD-7 on paper (0.80; 95% CI 0.75–0.86). McDonald’s omega values for the GAD-7 on a smartphone were also 0.83 (95% CI 0.76–0.88), and they were 0.83 (95% CI 0.76–0.88) for the GAD-7 on paper, indicating strong internal consistency. However, the ICCAs far as we could find, no studies have tested the equivalence of the electronic and paper versions of the K6 and GAD-7. However, previous studies have examined the equivalence of electronic and paper versions of the CES-D. A study of 2400 teachers in Taiwan, which tested the equivalence of the Internet-based CES-D and paper-based CES-D, found little difference in potential means and concluded that Internet-based CES-D is a promising alternative to paper-based CES-D [This study has several limitations. First, the study participants were a relatively young population, aged 18–22 years. Therefore, the results of this study may not apply to other age groups. Second, the influence of the carryover effects cannot be ignored. In a crossover design, a carryover effect may occur if the interval between the first and second evaluations is short. We tried to reduce the carryover effect as much as possible by keeping the interval between the first and second evaluations to 1 week. In fact, no statistically significant differences in the carryover effects were found in this study. However, given the lack of consensus on the ideal implementation interval when testing the equivalence of PROs [ | PMC10049019 | ||
Author Contributions | Conceptualization, K.H. and H.U.; methodology, K.H. and H.U.; formal analysis, H.U.; investigation, H.T. and N.K.; resources, K.H.; data curation, K.H. and H.U.; writing—original draft preparation, K.H. and H.U.; writing—review and editing, K.H., H.T., N.K., H.U., K.T. and S.K.; project administration, K.H.; funding acquisition, K.H. All authors have read and agreed to the published version of the manuscript. | PMC10049019 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethical Review Board for Medical Research Involving Human Subjects of Gunma University (Approval no. HS2022-109). | PMC10049019 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. Written informed consent has been obtained from the participants to publish this paper. | PMC10049019 | ||
Data Availability Statement | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC10049019 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the result. | PMC10049019 | ||
References | Depression, Anxiety, K6.CES-D | Flowchart of trial.Baseline characteristics of the two groups.Data are means (standard deviation) or numbers (%).Means (SD) and LMMs results.CES-D: Center for Epidemiologic Studies Depression Scale; GAD-7: Generalized Anxiety Disorder-7; K6: Kessler Screening Scale for Psychological Distress; SD: standard deviation; LMM: linear mixed models.Intragroup ICC (95% CI) for the CES-D, GAD-7, and K6.CES-D: Center for Epidemiologic Studies Depression Scale; GAD-7: Generalized Anxiety Disorder-7; K6: Kessler Screening Scale for Psychological Distress; ICC: intraclass correlation coefficient; CI: confidence interval.Internal consistency for CES-D, GAD-7, and K6.CES-D: Center for Epidemiologic Studies Depression Scale; GAD-7: Generalized Anxiety Disorder-7; K6: Kessler Screening Scale for Psychological Distress. | PMC10049019 | |
1. Introduction | AMD | DISEASES, CARDIOVASCULAR DISEASES | There is an urgent need to implement intervention programs to promote adherence to the Mediterranean diet (AMD) in university students to prevent non-communicable diseases. A powerful tool for this is smartphone apps. Furthermore, it is necessary to determine the subgroups that are most likely to benefit from these technologies. The objective is to evaluate the effectiveness of an app (e-12HR) at improving AMD in a sample of Spanish university students and different strata. The study method was a controlled and randomized clinical trial over a four-week follow-up period and involving 385 participants (76.9% women). The participants were in two parallel groups: the control group (CG) and the intervention group (IG), with only the IG receiving feedback to improve their AMD. There were significant statistical improvements (with higher values in the IG) at week four, after no significant statistical differences at baseline (Week One): in the whole sample: +25.7% AMD index and +74.5% percentage with moderate/high AMD index. In the subgroups, seven of eight subgroups, ranging in AMD index from +17.8% (≥20 years) to +33.0% (<20 years); and for males, in weeks two (+27.9%) and three (+23.9%), but not at week four. In conclusion, e-12HR could improve AMD among university students (in the total sample and all subgroups, except ≥25 kg/mUniversity students are particularly vulnerable to nutritional alterations mainly due to the fact that many are faced for the first time with the opportunity to make their own dietary choices [Numerous epidemiological and nutritional studies have shown that a healthy diet, such as the Mediterranean diet (MD), improves the quality of life and helps prevent several non-communicable diseases (NCDs) such as cardiovascular diseases [Although there is no single MD, common aspects of this healthy dietary pattern include a high intake of fruits, vegetables, legumes, and cereals; olive oil as the main fat; moderate amounts of dairy products and fish; and low amounts of meat and meat products [The degree of adherence to MD (AMD) of Spanish university students has been the subject of several studies, which have shown that more than half of these students had poor AMD [Several studies have analyzed the AMD in different population strata of university students (by age, gender, field of study and body mass index (BMI)). According to age group, gender, and BMI, the results were inconsistent. With respect to age group, various studies have shown that AMD increased as age did [University students are an important target audience for public health actions, as this is a stage where they can consolidate previously learned patterns or learn new ones to replace old ones, ultimately establishing their nutritional habits for the future [A powerful tool to promote and improve AMD among university students is the utilization of smartphone apps. Previously, the research team developed and validated a mobile app for measuring AMD called e-12HR [As a continuation of the research team’s previous studies, the main hypothesis of this work was that the previously mentioned factors influencing AMD [ | PMC10096856 |
2. Materials and Methods | PMC10096856 | |||
2.1. Design Overview | The present study is a continuation of previous research and follows the same study protocol, which has been described by Béjar et al. [ | PMC10096856 | ||
2.2. Setting and Participants | wasting, diabetes | WASTING, RECRUITMENT, CHRONIC DISEASES, DIABETES | The Faculties of Medicine, Pharmacy and Communication at the University of Seville (Andalusia, Spain, South of Europe) were included in the study.Confidentiality was guaranteed in accordance with the Organic Law on the Protection of Personal Data and the Law 14/2007 on Spanish biomedical research.Inclusion criteria: Both genders, over 18 years old, students of Medicine, Pharmacy and Communication (University of Seville) and possess a smartphone.Exclusion criteria: intolerance to any food, chronic diseases such as diabetes or pregnancy (situations which may require specific dietary recommendations).A member of the research group explained the study to potential participants, including objectives, risks and benefits of the research; e-12HR application functionalities; and how to participate (the students had to send an e-mail to the research team).When the research team received an e-mail from a student, they replied with another e-mail including the following documents: Document one: informed consent to be signed by the student and returned by e-mail; Document two: personal data (sex, date of birth, Faculty, weight, height, and smoking status) to be completed by the student and returned by e-mail; Document three: personal code (with numbers and letters); Document four: instructions for downloading e-12HR (a free app available on the App Store or Play Store); Document five: information for using e-12HR app; and Document six: information about the characteristics of the MD.This protocol was selected to obtain a high participation rate, avoid unnecessary travel to complete or sign documents, as well as to avoid wasting paper.Recruitment of participants: September–October 2022.The students who successfully completed the protocol were entered into the raffle for school materials (valued at EUR 500). | PMC10096856 |
2.3. Randomization and Masking | Four random classrooms were selected in each school (Medicine, Pharmacy and Communication): twelve classes in all. Of the four selected classrooms in each school, two were assigned to each group (CG and IG), according to the following sequence: first class: IG; second class: CG; third class: IG; and fourth class: CG. In this way, all students in the same class were assigned to the CG or the IG by probability single-stage cluster sampling.Due to the nature of the study, the students could not be blinded. However, the statistical analysis of the data was performed by a person who remained blinded throughout the study. In addition, each participant only had access to one version of the application (CG: ‘non-feedback’ e-12HR version; IG; ‘feedback’ e-12HR version). This was possible by assigning personal alphanumeric codes (mentioned in the previous section).The allocation sequence is detailed in | PMC10096856 | ||
2.4. Intervention | CG: ‘non-feedback’ e-12HR version.IG: ‘feedback’ e-12HR version.The structure and functions of the e-12HR application (‘non-feedback’ e-12HR and ‘feedback’ e-12HR versions) have been described, in detail, by Béjar et al. (in “e-12HR App” in the | PMC10096856 | ||
2.5. Follow-Up and Outcome Measures | In order to assess the effect of the app (‘feedback’ e-12HR), follow-up was carried out at week one (baseline), week two, week three and week four of monitoring.Main result variable: the change in the AMD score at weeks two, three and four of monitoring.Secondary result variables: the personal information variables, and the answers to the usability rating questionnaire for e-12HR (see | PMC10096856 | ||
Adherence to the MD | Every week during the four-week study period, the AMD index score (specifically, Mediterranean Diet Serving Score (MDSS) index [ | PMC10096856 | ||
2.6. Sample Size Calculation | The sample size estimation was made for the main result variable: the change in the MDSS index. Considering a standard deviation of 2.7 points in the MDSS index and a dropout rate of 20.6% (from a previous study using e-12HR [The sample size was calculated using the nQuery Advisor Release 7.0 program. | PMC10096856 | ||
2.7. Usability Rating Questionnaire for e-12HR | After the four-week monitoring period, a member of the research group sent e-mails to students (with a usability rating questionnaire for the e-12HR app [ | PMC10096856 | ||
2.8. Ethical Considerations | Participants were required to sign the informed consent prior to inclusion in the study, according to the Declaration of Helsinki.The study was approved by the University of Seville’s Research Ethics Committee on 30 March 2022 (internal identifier: 2813-N-21). Trial Registration: ClinicalTrials.gov, identifier NCT05532137. | PMC10096856 | ||
2.9. Statistical Analysis | The results were displayed as numbers (percentages) for qualitative variables and as means (standard deviations) for quantitative variables.The data were tested for normality using the nonparametric Kolmogorov–Smirnov test.In order to compare proportions, the chi-square test (or Fisher exact test) was carried out as appropriate, and Student’s A Statistical analyses: using the SPSS statistical software package version 26.0 (SPSS Inc., Chicago, IL, USA). | PMC10096856 | ||
3. Results | PMC10096856 | |||
3.1. Sample and Adherence to the Study | diabetic | A total of 491 students signed the informed consent forms; however, two students were excluded for being diabetic (one student from the IG and one from the CG), failing to meet the selection criteria. Of those who signed, 104 (64 in the CG and 40 in the IG) were considered to be non-responsive, as they did not complete the study’s 28-day follow-up period (Overall, the study response rate was 78.7% (385/489)–74.9% (191/255) in the CG, and 82.9% (194/234) in the IG- ( | PMC10096856 | |
3.3. MDSS Index | For both groups (CG and IG), scoring for the MDSS was calculated manually by the research team [ | PMC10096856 | ||
3.4. Effect of the Intervention | PMC10096856 | |||
3.4.1. Effect of the Intervention in Terms of Variation in MDSS Index and Percentage of Participants with Moderate/High (≥9) MDSS Index in the Whole Study Sample | There were significant statistical differences for both the MDSS index and the percentage of participants with moderate/high (≥9) MDSS index (CG versus IG) in weeks two, three and four, with higher values in the IG (no significant differences in week one): for the MDSS index with 1.25, 1.78 and 1.93 points of improvement, respectively, and for the percentage of participants with moderate/high (≥9) MDSS index with increases of 19.2, 20.7 and 24.2 percentage points, respectively ( | PMC10096856 | ||
3.4.3. Effect of the Intervention in Terms of Variation in MDSS Index in Different Subgroups of the Study Sample | The differences were statistically significant considering the MDSS index (CG versus IG): in weeks two, three and four for the subgroups <20 years, female, Health Science and <25 kg/m | PMC10096856 | ||
3.5. Usability Rating Questionnaire for e-12HR | This questionnaire was answered by 127 students (66 from the CG and 61 from the IG).The responses of the users are shown in Considering the 127 participants who answered the questionnaire, all (100%) reported that e-12HR was easy to complete, and most of them indicated that: (1) the application contained understandable questions (97.0% CG and 91.8% IG); (2) the app contained understandable feedback (only for the IG, 85.2%); (3) they would be willing to complete the e-12HR app again, (53.0% CG and 63.9% IG); and (4) the time to complete the task was 2 min or less (56.1% CG and 57.4% IG). There were no statistically significant differences (CG versus IG) for any of the questions on the questionnaire ( | PMC10096856 | ||
4. Discussion | Velicer, AMD | Few randomized and controlled clinical trials have analyzed the effectiveness of promoting the MD (in Spanish adults) of smartphone apps with certain similarities to e-12HR [The main findings of this work were (significant intergroup statistical modifications): First: in relation to the main objective, in the entire sample of Spanish university students, the increase in AMD from week two throughout the follow-up of the study (at week four the increase was favorable to IG versus CG by +25.7% for MDSS index and by +74.5% for the percentage of participants with moderate/high (≥9) MDSS index) (The increase in MDSS index (CG versus IG) with the use of e-12HR can be considered moderate (with higher values in the IG): in the entire sample of university students, +25.7%; in the subgroups, ranging from +17.8% (for ≥20 years) to +33.0% (for <20 years). However, this moderate increase among university students could be considered, at the same time, promising. University students are not characterized by being in high motivation stages to change a lifestyle factor (preparation or action, following the model of Prochaska and Velicer [As previously mentioned, some randomized and controlled clinical trials have used applications with certain similarities to e-12HR to improve AMD in Spanish adults [This study presents several limitations. First, all the data collected were self-administered: the participants completed the daily nutrition questionnaire using the app (e-12HR being a self-reporting method, it presents the inherent limitations of this type of tool, described in detail in the bibliography [ | PMC10096856 | |
Future Research Related to the Current Study | AMD | In those subgroups of the population that have improved AMD with the use of e-12HR, the research team intends to evaluate the possible increase in the MDSS index by combining the use of the app with counseling (counseling focused on food groups that have not improved consumption with the use of e-12HR, such as eggs, white meat, red meat, etc.): CG (‘non-feedback’ e-12HR version) versus IG (‘feedback’ e-12HR version + counseling) [ | PMC10096856 | |
5. Conclusions | AMD | The results of this study support recommending the use of e-12HR in university students as a tool to improve AMD in the short term, in the total sample and in all its subgroups, except ≥25 kg/m | PMC10096856 | |
Author Contributions | Conceptualization, L.M.B.; methodology, L.M.B.; software (app design), L.M.B.; formal analysis, A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; investigation, L.M.B., P.M.-R., A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; resources, L.M.B., P.M.-R., A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; data curation, M.D.G.-P.; writing—original draft preparation, L.M.B., P.M.-R., A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; writing—review and editing, L.M.B., P.M.-R., A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; visualization, L.M.B., P.M.-R., A.Q.-F., M.d.M.R.-A. and M.D.G.-P.; supervision, L.M.B.; project administration, M.D.G.-P.; funding acquisition, P.M.-R. All authors have read and agreed to the published version of the manuscript. | PMC10096856 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the University of Seville’s Research Ethics Committee on 30 March 2022 (identifier: 2813-N-21). | PMC10096856 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10096856 | ||
Data Availability Statement | The data used in the current study are available on reasonable request from the corresponding author. | PMC10096856 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10096856 | ||
Abbreviations | PMC10096856 | |||
Appendix A | Usability Rating Questionnaire for e-12HR.1: Strongly agree. 2: Agree. 3: Neither agree nor disagree. 4: Disagree. 5: Strongly disagree. | PMC10096856 | ||
1. Introduction | gastrointestinal tract, upper gastrointestinal tract | Almonds are rich in unsaturated lipids, which play a role in some of the reported benefits of almond consumption for human health. Almond lipids are poorly bioaccessible due to almonds’ unique physicochemical properties that influence particle size distribution (PSD) following mastication, allowing much intracellular lipid to escape digestion in the upper gastrointestinal tract. To investigate the impact of commercial processing (grinding almonds into flour), on PSD and predicted lipid bioaccessibility following mastication, a randomised cross-over design mastication study was conducted in healthy adults. The PSDs of masticated whole and ground almonds was assessed using two laboratory methods (mechanical sieving and laser diffraction). PSD from mechanical sieving was used to calculate lipid bioaccessibility using a theoretical mathematical model. Thirty-one healthy adults (18–45 years) completed both mastication sessions. Following mastication, ground almonds had a PSD with significantly fewer larger particles and more smaller particles, compared with whole almonds. Predicted lipid bioaccessibility of masticated ground almonds (10.4%, SD 1.8) was marginally but significantly greater than the predicted lipid bioaccessibility of masticated whole almonds (9.3%, SD 2.0; Nuts are rich in fibre, polyphenols and unsaturated lipids [The term “bioaccessibility” refers to the proportion of a nutrient released from a complex food matrix that is therefore potentially available for absorption in the gastrointestinal tract [The impact of mastication and processing on particle size distribution (PSD) and lipid bioaccessibility has been demonstrated in experiments in which almonds were subjected to simulated mastication whereby almonds were first minced, to simulate the mechanical breakdown of food, and then mixed with salivary enzymes [The impact of commercial processing on almond lipid bioaccessibility has important implications for human health. A systematic review and meta-analysis including trials investigating the impact of nuts on gut microbiota and gut health related outcomes revealed almond specific effects on gut microbiota composition at the genus level, and α-diversity [A recent randomised controlled trial (RCT) [The PSD and nutrient bioaccessibility of almonds have not been extensively explored and the impact of commercial grinding of almonds on PSD and lipid bioaccessibility is unknown. The majority of studies reporting health benefits of almonds have tested the effects of whole almonds, and attributed benefits to nutrient content of almonds. Thus, the investigation of nutrient bioaccessibility following processing may have important implications for human health. We therefore performed a randomised mastication study with the aim to: (a) measure and compare the PSDs of masticated whole and ground almonds, using two different techniques; and (b) compare the predicted lipid bioaccessibility of masticated whole and ground almonds. | PMC9919979 | |
2. Materials and Method | PMC9919979 | |||
2.1. Study Design | This study was a randomised, crossover design mastication study in healthy volunteers consisting of a single study visit with two mastication sessions. A mastication study is required as mastication has a key role in reducing PSD and reflects the presentation of almonds as they appear in the gut in vivo. It has been demonstrated that there is large inter-individual variability in masticatory parameters such as the number and duration of mastication cycles, and that PSDs are dependent on food type [Therefore, a within-subjects design was determined to be most appropriate to compare the PSDs and lipid bioaccessibility of whole and ground almonds. Randomisation was performed by an independent researcher, using the online randomisation website sealedenvelope.com (Sealed Envelope Ltd. 2020, London, UK). Participants were assigned to one of two sequences (whole almonds followed by ground almonds; ground almonds followed by whole almonds) in a 1:1 ratio. The sequence was concealed from researchers in sealed envelopes that were opened at the mastication study visit. Mastication sessions took place at the Metabolic Research Unit, King’s College London. | PMC9919979 | ||
2.2. Participants | Participants were those who had previously completed an RCT investigating the impact of almond consumption on gut health [ | PMC9919979 | ||
2.3. Collection of Mastication Samples | pain | Incomplete dentition, presence of dentures/false teeth and/or recent dental treatment were considered as confounding factors that may impact (1) normal masticatory behaviour due to pain or discomfort in part of the mouth or (2) particle recovery due to lodgement of particles in oral crevices. These data were collected from participants prior to study visit.Whole and ground almonds were provided by the Almond Board of California. To facilitate consumption, ground almonds were mixed with water to form a paste prior to mastication (2.7 mL water was added to each 5 g aliquot of ground almond). In order to record the number of mastication cycles taken by each participant, mastication and swallowing were observed separately for each almond form prior to sample collection. Briefly, participants brushed their teeth before chewing two aliquots of each test food (either whole or ground almonds; random order; 5 g per aliquot) under the observation of a study researcher who counted the number of mastication cycles (chews) taken prior to swallowing. Mean number of mastication cycles for each almond form was calculated.During the mastication experiment, participants were asked to chew (for the mean number of cycles calculated previously) three pre-weighed aliquots of either whole or ground almonds (approx. 5 g each) and without swallowing any almond were asked to expectorate all aliquots into the same pre-weighed beaker fitted with a 20 μm nylon mesh. Participants rinsed their mouth with 25 mL water after each aliquot and expectorated into the same beaker to maximise recovery of almond particles from the mouth. Participants brushed their teeth once again and the session was repeated for the second test food.Beakers were allowed to stand for 20 min to allow saliva and rinse water to pass through the 20 μm nylon mesh. The nylon mesh was inserted into a falcon tube, and centrifuged at 400× | PMC9919979 | |
2.4. Mechanical Sieving | Samples were thawed at 4 °C and loaded onto a stack of pre-weighed ultra-sonically cleaned sieves (Endecotts Ltd., London, UK) with the following aperture sizes from top to bottom: 3350, 2000, 1000, 500, 250, 125, 63 and 45 µm, a 20 µm nylon mesh and a sieve base. The sample was washed with deionised water before being placed on a mechanical sieve shaker (Endecotts Ltd., UK) for 15 min to allow the masticated almonds particles to pass through the sieves until they reached the sieve with an aperture size smaller than the size of that particle. Sieves were washed with deionised water to facilitate movement of lodged particles down through the sieve tower. To remove all water, leaving only the masticated almond samples, all sieves were then placed in a forced air oven at 56 °C for 24 h after which each sieve was weighed at 15 min intervals until a constant weight was reached (within 0.1 g). Oven temperature was increased to 80 °C and sieve bases were dried for a further 12 h, after which each sieve was weighed at 15 min intervals until weight was constant.For PSD analysed by mechanical sieving, the proportion of masticated almonds retained on each sieve was expressed as a percentage of the total weight of sample recovered from the sieves (% weight; not including the contents of the sieve base). | PMC9919979 | ||
2.5. Laser Diffraction | Samples were thawed at 4 °C. Particles >2000 µm and <20 µm were removed by mechanical sieving prior to analysis to avoid interference with the laser diffraction instrument as described previously [Laser diffraction was performed on a Mastersizer 2000 instrument fitted with a Hydro 2000 G dispersant unit (Malvern Panalytical Ltd., Malvern, UK). The settings on the MasterSizer were as follows: pump speed, 700; stirrer speed, 1175; ultrasound, 70 [For PSD analysed by laser diffraction, mean PSD at each particle size interval was calculated from individual aliquots. The proportion of the sample in each particle size interval was expressed as a percentage of the total sample volume (% volume). | PMC9919979 | ||
2.6. Predicted Lipid Bioaccessibility | A theoretical model for predicting lipid bioaccessibility in almonds has been developed previously [ | PMC9919979 | ||
2.7. Statistical Analysis | Data were analysed on IBM SPSS Statistics (version 26; IBM, Portsmouth, UK). Descriptive statistics were used to summarise demographic characteristics and outcome data. For continuous outcomes, mean and standard deviation were calculated.Summary data for PSD were presented as mean % weight (mechanical sieving) or mean % volume (laser diffraction) and standard deviation (SD). To assess inter-individual variation at each level of particle size, a coefficient of variation (CV) was calculated for each sieve aperture size within each almond type using the formula: CV (%) = (SD/mean) × 100.Before analysis, all continuous raw data were checked for normality and outliers using Q-Q plots and the Shapiro–Wilk test. Student’s paired | PMC9919979 | ||
3. Results | PMC9919979 | |||
3.1. Particpant Characteristics | The consort diagram is presented in | PMC9919979 | ||
3.2. Masticatory Parameters | Data were gathered on each participant’s dentition, the results of which are presented in | PMC9919979 | ||
3.3. Particle Size Distribution Assessed by Mechanical Sieveing | The mean total weight of particles recovered was significantly different ( | PMC9919979 | ||
3.4. Particle Size Distribution Assessed by Laser Diffraction | The PSD of masticated whole and ground almonds as assessed by laser diffraction is illustrated in | PMC9919979 | ||
3.5. Predicted Lipid Bioaccessibility | Lipid bioaccessibility of masticated whole and ground almonds was predicted using the theoretical model with data obtained from particle size analysis by mechanical sieving (The model indicated a threshold particle size value (P) of approximately 54 µm for almonds. Thus, to obtain complete lipid release, all particles would need to be smaller than 54 µm. Masticated whole almond samples contained significantly fewer particles <54 µm (11.5%, SD 1.7) in comparison to masticated ground almonds (12.6%, SD 1.5; | PMC9919979 | ||
4. Discussion | weight loss | SEPARATION | This mastication study was conducted to test the hypotheses that mastication of commercially ground almonds would result in a PSD with smaller particles in comparison to whole almonds, and that this would influence subsequent predicted lipid bioaccessibility. Our results support the above hypotheses; there were differences in PSDs in which masticated ground almonds had significantly more particles <150 µm, and masticated whole almonds had significantly more particles >1000 µm. This resulted in a modest, but significantly greater predicted lipid release from masticated ground almonds, in comparison to masticated whole almonds.We confirm the results of previous studies demonstrating that following mastication whole almonds have a wide PSD, including many larger particles that prevent complete lipid release during digestion, with one study reporting masticated whole almonds containing 35–40% of particles >500 µm [There were significant differences in the number of mastication cycles required for whole and ground almonds. This variability is supported by previous suggestions that masticatory performance is determined by the requirement that a food bolus reaches a precisely determined texture before it can be swallowed [It is important to note the significant inter-individual variability in PSDs following mastication as indicated by large CVs (ranging from 0–100% for laser diffraction and 27–154% for mechanical sieving; Interestingly, the PSD profile of masticated ground almonds appeared to be bimodal when assessed using both measurement methods, with a peak in the proportion of particles recovered on the 45 µm sieve and the corresponding level of particle size for laser diffraction, and another larger peak in proportion of particles recovered on the 500 µm sieve or around the 1000 µm level for laser diffraction. This was not the case for whole almonds, which had a peak in proportion of particles recovered on the 1000 µm sieve only. This potentially indicates an uneven distribution of particle sizes following the grinding process, whereby certain particle sizes are over-represented following grinding and mastication has no further effect at these sizes. This theory is supported by research reporting that the granularity of a food during mastication must reach a predetermined state before swallowing is initiated, and that this is achieved by a highly individualised chewing strategy [This was the first study to analyse the lipid bioaccessibility from masticated commercially ground almonds. Predicted lipid bioaccessibility from masticated whole almonds was 9.3%, which agreed with previous analyses of lipid release from masticated whole almonds measured by Soxhlet extraction (7.8–11.1%) and predicted using the theoretical model (9.6%) [Bioaccessibility is only one factor that has an impact on the almond lipids available for absorption. Factors such as total fatty acid content of different almond harvests and method of storage will also influence the almond lipids available for absorption and their subsequent impact on human health [The results of the current study are not representative of the impact of later stages of digestion on lipid release from almond cells. The impact of enzymatic digestive processes in the stomach and duodenum on lipid release from almond cells would be technically difficult to measure in humans, and would require consumption of almonds in isolation over a prolonged period, a method that would have considerable practical and ethical implications [In the current study, PSD data from analysis of masticated almonds by mechanical sieving was used to predict lipid bioaccessibility using a theoretical model [We have demonstrated that both whole and ground almonds have PSDs that prevent complete lipid release during the first stage of digestion (mastication), and that this would likely result in lower metabolizable energy than predicted by Atwater factors when consuming these forms of almond. This has important implications for human health. In groups that could benefit from increased energy consumption, for example for recovery following injury, or in the elderly, it might be recommended that consuming almonds in a processed form (ground almonds, almond butter) is beneficial. Conversely, our findings support the evidence that despite their high lipid content and energy density, whole almonds can be added to the diets of those attempting weight loss without impacting this outcome [To our knowledge this is the first trial to investigate the impact of commercial grinding on the PSD and predicted lipid bioaccessibility of almonds. Limitations of the trial include storage of almonds prior to particle size analysis, which may result in further breakdown of almond particles due to the action of salivary enzymes, together with the mechanical forces of freezing. To limit these effects, masticated almond samples were snap frozen on dry ice prior to storage at −80 °C. At such temperatures, salivary enzymes are no longer active.It was not possible to calculate the total % recovery of the original weight of almonds that were masticated due to (1) separation of the masticated almond samples into aliquots for analysis; and (2) the contrasting outcome data of the methods (sieving—% weight; laser diffraction—% volume). Mastication sessions and sample collection were conducted based on previously published research, that reported 85.4% (SD 1.5%) recovery following mastication of whole natural almonds [ | PMC9919979 |
5. Conclusions | In conclusion, we confirm that mastication does not provide sufficient mechanical disruption to result in a PSD that facilitates complete lipid release from whole almonds. In addition, commercial processing of almonds by grinding results in a post-mastication PSD with a larger proportion of smaller particles, and a subsequent modest increase in predicted lipid bioaccessibility compared to the results following mastication of whole almonds. However, it is unlikely that the difference in lipid bioaccessibility is sufficient to result in clinically meaningful differences to human health outcomes, for example gut microbiota composition. Future studies are needed to investigate the impact of alternative almond processing methods, for example grinding of almonds into butter (almost complete lipid release, but also change in cell matrix [ | PMC9919979 | ||
Author Contributions | Conceptualisation and methodology, K.W., S.E.B., E.D. and A.C.C. in consultation with T.G.; investigation, A.C.C. and E.S.H.; data curation, A.C.C.; formal analysis, A.C.C. under supervision of K.W. and S.E.B., and support from T.G. (predicted lipid bioaccessibility); writing—original draft preparation, A.C.C.; writing—review and editing, K.W. and S.E.B.; All authors have read and agreed to the published version of the manuscript. | PMC9919979 |
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