title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC10094525 | ||
Trial Registration | The study is registered at | PMC10094525 | ||
Abbreviations | CORONAVIRUS DISEASE 2019 | CI: confidence intervals; CON: Standard care; COVID-19: coronavirus disease 2019; EXE: Structured, supervised exercise training; GA: gestational age; MOT: Motivational counseling on physical activity; MVPA: Moderate-to-vigorous-intensity physical activity; PA: Physical activity; PSQI: Pittsburgh Sleep Quality Index; PP... | PMC10094525 | |
References | Baseline-constrained comparison between groups based on the means of the Pittsburgh Sleep Quality Index global score. Baseline, gestational age of maximum 15 weeks; CON (gray color), standard care; EXE (blue color), structured supervised exercise training; GA, gestational age; MOT (red color), motivational counseling o... | PMC10094525 | ||
Background | bleeding, pneumonia, peritonitis | BLEEDING, PNEUMONIA, WOUND INFECTION, PERITONITIS, LEAKAGE, COMPLICATIONS | Percutaneous endoscopic gastrostomy (PEG) is commonly chosen for long-term enteral nutrition support. However, common complications of PEG include wound infection, leakage, obstruction, bleeding, dislodgement, pneumonia, peritonitis, and more. The anticipation of these complications by both patients and their family ca... | PMC10625096 |
Objective | COMPLICATIONS | This study aimed to establish and compare a health education program utilizing a tracking system for PEG using a mobile app (PEG app) and instant messaging software versus a paper-based health education program with instant messaging software. Their effectiveness in preventing complications, avoiding hospital readmissi... | PMC10625096 | |
Methods | A randomized controlled trial design was used, and the study sample consisted of patients from a medical center in central Taiwan who underwent thoracic surgery or gastroenterology procedures. Inclusion criteria were being a new case undergoing his or her first gastric tube insertion and having the ability to operate a... | PMC10625096 | ||
Results | COMPLICATIONS | The experimental group demonstrated a significant reduction in the occurrence of complications compared with the control group ( | PMC10625096 | |
Conclusions | COMPLICATIONS | Integration of the PEG app with instant messaging can enhance self-care ability, improve social aspects of quality of life, and reduce complications. The study results suggest that the PEG app could be used as an adjunct tool to promote patients’ self-directed management of their gastric tube at home, particularly for ... | PMC10625096 | |
Trial Registration | Chinese Clinical Trial Registry ChiCTR2300071271; https://tinyurl.com/4vvy584e | PMC10625096 | ||
Introduction | voice and visual information, bleeding, pneumonia, peritonitis | BLEEDING, PNEUMONIA, WOUND INFECTION, DISEASE, PERITONITIS, LEAKAGE, COMPLICATIONS | Percutaneous endoscopic gastrostomy (PEG) is a preferred method for long-term enteral nutrition support. Studies indicate that 5% to 7.8% of nursing home residents receive gastrostomy feeding [Common complications of PEG include wound infection (3%-50%), leakage (10%-42.3%), obstruction (8%-35%), bleeding (32%), dislod... | PMC10625096 |
Methods | PMC10625096 | |||
Study Design | This study used a randomized controlled trial design with a study period spanning from August 7, 2018, to December 31, 2022. Random allocation was achieved using computer-generated grouping, with numbers assigned and placed in sealed envelopes. Envelopes were drawn by cases at the time of enrollment to determine group ... | PMC10625096 | ||
Recruitment | death | COMPLICATIONS | A total of 82 patients underwent initial catheter placement. After excluding 6 patients who refused participation, 76 patients were randomized and assigned to respective groups, with 38 patients in each group for the study. During the 1-month follow-up period, there was 1 death owing to complications of chemotherapy in... | PMC10625096 |
Research Site and Participants | The study was conducted at a prestigious medical center located in the central region of Taiwan. Inclusion criteria for the study were as follows: (1) patients who were undergoing their first PEG placement; (2) patients who had access to mobile devices such as smartphones, tablets, or computers; (3) patients or their c... | PMC10625096 | ||
Sample Size Estimation for Power Calculation | WOUND INFECTION, COMPLICATION | The sample size estimation for power calculation was grounded in the primary outcome measure, which focused on the most common complication—wound infection. This approach was inspired by the work of Pattison and Young [ | PMC10625096 | |
Randomization and Groups | redness, voice, swelling, pain | STERILE, EVENT, HEAT, COMPLICATIONS | The research tool involves the completion of a “Participant Consent Form” by the patient or their legal representative, followed by random allocation to either the intervention group or the control group through a drawing of lots. Patients in the intervention group had the mobile device app “Percutaneous Endoscopic Gas... | PMC10625096 |
Research Instruments and Assessment of Reliability and Validity | WOUND INFECTION, COMPLICATIONS, COMPLICATION | Regarding hardware, the mobile devices included smartphones, tablets, computers, a server, a thermometer, and a scale. Regarding software, the PEG tracking system was compatible with Android or iOS mobile devices or desktop computers with the Windows operating system, and the Line app allowed real-time communication. T... | PMC10625096 | |
Outcome Measures | COMPLICATIONS | Data collection took place at 2 specific time points: initially, before the intervention began to gather demographic information and assess self-care knowledge. Subsequently, data collection occurred after the intervention, within 1 week of the completion of the 1-month study period, to assess complications, quality of... | PMC10625096 | |
Primary Outcomes | COMPLICATIONS | Following the health-social approach model, complications and quality of life were the primary outcome measures. | PMC10625096 | |
Complications | bleeding, pneumonia | BLEEDING, PNEUMONIA, WOUND INFECTION, LEAKAGE, COMPLICATIONS | Complications including wound infection, leakage, migration, pneumonia, granulation, bleeding, admission to the emergency department within 3 days, and hospital readmission within 14 days were assessed. | PMC10625096 |
World Health Organization Quality of Life Brief Version | In 1995, the World Health Organization (WHO) established a quality of life questionnaire (WHOQOL) that includes the following 4 major domains: psychological, physiological, social, and environmental. The domains use a 5-point Likert scale. A score of 1 represents ”very dissatisfied,“ 2 represents ”dissatisfied,“ 3 repr... | PMC10625096 | ||
Secondary Outcomes | PMC10625096 | |||
Self-Care Knowledge Assessment | COMPLICATIONS | The self-care knowledge assessment primarily evaluated the level of understanding by individuals or primary caregivers about self-care for gastric tubes, based on the following 4 dimensions: wound care, tube feeding, complications, and emergency medical care. A self-designed questionnaire with 10 items assessed self-ca... | PMC10625096 | |
Self-Care Ability | COMPLICATIONS | The self-designed questionnaire for self-care ability primarily assessed the level of competence in performing gastric tube care behaviors by patients or primary caregivers. It covers the following 3 dimensions: measures for tube feeding, prevention of complications, and observation of symptoms of complications. The se... | PMC10625096 | |
Ethical Considerations | This study was approved by the Human Research Ethics Review Committee of Taichung Veterans General Hospital (on August 7, 2018; institutional review board number: CF18189A-1). | PMC10625096 | ||
Data Processing and Statistical Analysis | Descriptive analysis was performed using SPSS 26.0, while inferential statistical analysis involved chi-square tests, independent | PMC10625096 | ||
Discussion | PMC10625096 | |||
Principal Findings | esophageal cancer, redness, tumor, fever, swelling, shock, cancer, pain, infection, deterioration of wound infections | TUMOR, OESOPHAGEAL CANCER, SHOCK, CANCER, WOUND INFECTION, COMPLICATION, INFECTION, LEAKAGE, HEAT, COMPLICATIONS | The research findings demonstrated that using the PEG and Line apps can improve self-care behaviors, reduce complications, and enhance quality of life at the social level. The experimental group demonstrated significantly better self-care abilities than the control group. In terms of behavior change and habit formation... | PMC10625096 |
Limitations | In terms of research limitations, the participants knew to which group they belonged, which might have introduced potential biases and limitations to the objectivity of data collection, as blinding was not possible. Therefore, for future studies, it is recommended to involve personnel other than the researchers themsel... | PMC10625096 | ||
Conclusions | COMPLICATIONS | The group using the PEG app indicated significant improvements in self-care abilities, reduced complications, and better social support in terms of quality of life compared with the control group. These findings highlight the benefits of the PEG app for home-based postoperative care of patients with gastrostomy tubes. ... | PMC10625096 | |
Abbreviations | content validity indexmobile healthpercutaneous endoscopic gastrostomyWorld Health OrganizationWorld Health Organization Quality of Life Brief Version | PMC10625096 | ||
Background | Obesity, heterogenous asthma, asthma, CWP, weight loss | OBESITY, ASTHMA | Obesity is often associated with uncontrolled, difficult-to-treat asthma and increased morbidity and mortality. Previous studies suggest that weight loss may improve asthma outcomes, but with heterogenous asthma populations studied and unclear consensus on the optimal method of weight management. The Counterweight-Plus... | PMC10808069 |
Research Question | obesity, difficult-to-treat asthma, UC, asthma, CWP | OBESITY, ASTHMA | Can use of the CWP compared with usual care (UC) improve asthma control and quality of life in patients with difficult-to-treat asthma and obesity? | PMC10808069 |
Study Design and Methods | CWP, difficult-to-treat asthma | We conducted a 1:1 (CWP to UC) randomized, controlled single-center trial in adults with difficult-to-treat asthma and BMI of ≥ 30 kg/m | PMC10808069 | |
Results | Weight loss, CWP, UC | Thirty-five participants were randomized (36 screened) and 33 attended the 16-week follow-up (n = 17 in the CWP group, n = 16 in the UC group). Overall, mean ACQ6 score at baseline was 2.8 (95% CI, 2.4-3.1). Weight loss was greater in the CWP than UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4; | PMC10808069 | |
Interpretation | obesity, asthma, UC | OBESITY, ASTHMA | Using a structured weight management program results in clinically important improvements in asthma control and quality of life over 16 weeks compared with UC in adults with difficult-to-treat asthma and obesity. This generalizable program is easy to deliver for this challenging phenotype. Longer-term outcomes continue... | PMC10808069 |
Trial Registry | ClinicalTrials.gov; No.: NCT03858608; URL: | PMC10808069 | ||
Graphical Abstract | PMC10808069 | |||
Key Words | PMC10808069 | |||
Abbreviations | ASTHMA | Asthma Control Questionnaire 6Asthma Quality of Life QuestionnaireCounterweight-Plus Programmefractional exhaled nitric oxideinterquartile rangeminimal clinically important differencetotal diet replacementusual care
FOR EDITORIAL COMMENT, SEE | PMC10808069 | |
Study Design and Methods | obesity, UC, asthma, CWP, weight loss | OBESITY, ASTHMA | In this randomized, controlled, open-label, parallel study of a TDR weight loss program compared with usual care (UC) in individuals with difficult-to-treat asthma and obesity, participants were randomized 1:1 using a password-protected, online, third-party randomization service to CWP or UC. | PMC10808069 |
Participants | Eligible participants 18 to 75 years of age with BMI of ≥ 30.0 kg/m | PMC10808069 | ||
Measurements | Anxiety, asthma, dyspnea | THORACIC, ASTHMA, ASTHMA | Baseline demographics, asthma and other medical history, and medication information were obtained at visit 1. At all visits, the Asthma Control Questionnaire 6 (ACQ6) and Asthma Quality of Life Questionnaire (AQLQ) scores were recorded. The ACQ6 is a validated asthma control score comprising six questions,At all visits... | PMC10808069 |
Counterweight-Plus Program | CWP, weight loss | The CWP consisted of three phases: TDR (0-12 weeks), food reintroduction (13-18 weeks), and weight loss maintenance (19-52 weeks) and was delivered by experienced dietitians with CWP training ( | PMC10808069 | |
Usual Care | asthma | DISEASE, ASTHMA, SECONDARY | Standard asthma care was continued in all participants in all groups. This included continuation of previously initiated asthma medication, but also modification of asthma treatment based on clinical need; those with worsening asthma received treatment escalation, whereas those with improving disease or lack of treatme... | PMC10808069 |
Primary Outcome | CWP, UC | The primary outcome was difference in change in ACQ6 score from baseline (visit 1) to 16 weeks (visit 2) between the CWP and UC groups. | PMC10808069 | |
Secondary Outcomes | CWP, UC | Secondary measures included difference in change in AQLQ score from baseline to 16 weeks between CWP and UC groups, overall and in each AQLQ domain (symptoms, activity, emotional, and environmental), and the difference in proportion of participants with ≥ 0.5 change (MCID in ACQ6 | PMC10808069 | |
Sample Size | CWP, UC | To demonstrate a difference of 0.5 between mean changes in ACQ6 score in CWP and UC groups from baseline to 16 weeks, based on an SD of 0.5 from a similar population, | PMC10808069 | |
Statistical Analysis | Participants attending visits 1 and 2 were included for intention-to-treat analysis. Continuous variables were described as mean (95% CI) or median (interquartile range [IQR]) based on distribution and compared using independent | PMC10808069 | ||
Results | PMC10808069 | |||
Participation and Baseline Characteristics | CWP, ABPA | ABPA, ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS, ASTHMA | Participants were recruited from August 2019 through August 2021, with 2-year follow-up scheduled to finish in August 2023. Sixteen-week follow-up visits continued until December 2021. Of 36 participants screened, one was ineligible (Consolidated Standards of Reporting Trials flow chart.Overall, mean age was 53 years, ... | PMC10808069 |
Primary Outcome | CWP, UC | ASTHMA | Over 16 weeks, mean change in ACQ6 score was –0.45 (95% CI, –1.02 to 0.13) for the CWP group and 0.23 (95% CI, –0.17 to 0.63) for the UC group, with a mean difference of –0.69 (95% CI, –1.37 to –0.01; Intention-to-Treat Comparison of Asthma Control and Quality-of-Life Outcomes Between CWP and UC Groups Over 16 WeeksDat... | PMC10808069 |
Secondary Outcomes | CWP | Over 16 weeks, mean change in overall AQLQ score was 0.81 (95% CI, 0.28-1.35) for the CWP group and 0.08 (95% CI, –0.32 to 0.48) for the UC group, with a mean difference of 0.76 (95% CI, 0.18-1.34; Bar graph showing the proportion of participants achieving minimal clinically important difference in ACQ6 and AQLQ scores... | PMC10808069 | |
Other Outcomes | CWP, weight loss, UC | EVENTS | Mean weight loss was –13.5 kg (95% CI, –17.5 to –9.6) for the CWP group and –1.4 kg (95% CI, –3.2 to 0.4) for the UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4 kg; Intention-to-Treat Comparison of Other Outcomes Between CWP and UC GroupsData are presented as mean (95% CI) for parametric data or median (int... | PMC10808069 |
Per-Protocol Analysis | CWP | Of the 33 participants attending visit 2, two participants did not tolerate CWP ( | PMC10808069 | |
Weight Loss Extent and Change in ACQ6 and AQLQ Scores | CWP, weight loss | ASTHMA | Post hoc analysis of changes in ACQ6 and AQLQ scores with CWP in groups based on extent of total body weight loss (< 10%, 10%-15%, and ≥ 15%) showed trends toward greater benefit with greater weight loss (Post Hoc Comparison of Asthma Control and Quality of Life With CWP by Percentage Weight LossData are presented as m... | PMC10808069 |
Adverse Events | migraine, CWP, asthma, COVID-19 gastroenteritis | ADVERSE EVENTS, MIGRAINE, ASTHMA, COVID-19 PNEUMONITIS | No unexpected serious adverse events or intervention-related adverse events occurred during the trial. Overall, five participants were hospitalized during the 16-week period: three participants in the UC group (one participant with a ward level exacerbation of asthma, one participant with exacerbation of asthma requiri... | PMC10808069 |
Discussion | obesity, exertional breathlessness, difficult-to-treat asthma, obesity-associated asthma, UC, overweight, asthma, CWP, weight loss | OBESITY, ASTHMA | In this pragmatic open-label, randomized, controlled trial, we showed that delivery of a supported low-calorie total diet replacement program (Counterweight-Plus) to patients with difficult-to-treat asthma and obesity was safe and led to significant improvements in asthma control and quality of life compared with UC ov... | PMC10808069 |
Interpretation | obesity, dyspnea, UC, asthma, CWP | OBESITY, ASTHMA | Compared with UC, use of the CWP weight management program with dietitian support improved asthma control and quality of life as well as dyspnea and anthropomorphic measures over 16 weeks in individuals with difficult-to-treat asthma and obesity. Further research is needed to confirm the longer-term outcomes and to ide... | PMC10808069 |
Funding/Support | This study was funded by an NHS Greater Glasgow and Clyde Endowment fund. | PMC10808069 | ||
Financial/Nonfinancial Disclosures | The authors have reported to | PMC10808069 | ||
References | PMC10808069 | |||
Supplementary Data | PMC10808069 | |||
e-Online Data | PMC10808069 | |||
Introduction | migraine, headache | MIGRAINE, HEART, ADVERSE EVENTS, PRIMARY IMMUNODEFICIENCY | Edited by: Francisco Javier Espinosa-Rosales, Fundación Mexicana para Niñas y Niños con Inmunodeficiencias (FUMENI), MexicoReviewed by: Marco Antonio Yamazaki-Nakashimada, National Institute of Pediatrics, Mexico; Soo Jin Cho, Hallym University Dongtan Sacred Heart Hospital, Republic of KoreaThis article was submitted ... | PMC9932595 |
Methods | migraine, headache | MIGRAINE | We analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex | PMC9932595 |
Results | Headache, headaches, headache, migraines, migraine | MIGRAINE, MIGRAINES | In total, 1482 infusions were administered to 123 patients, with 94.6% of infusions achieving the maximum infusion rate. At least one product-related headache was reported in 6.1% (90/1482) of infusions. At least one product-related migraine was reported in 0.5% (7/1482) of infusions. Headache rates were higher for adu... | PMC9932595 |
Discussion | migraine, headache | MIGRAINE | Patients receiving this IVIG product on a 15-minute rate escalation protocol had low rates of headache and migraine for both the 5% and 10% formulations. | PMC9932595 |
Introduction | primary immunodeficiency disorders | Intravenous immune globulin (IVIG) is a standard therapy for the treatment of primary immunodeficiency disorders (GammaplexBecause PI is rare, trials of IVIG in patients with PI tend to be small, with most late-phase clinical trials of these agents involving 50 or fewer patients ( | PMC9932595 | |
Materials and methods | This was an exploratory retrospective analysis of data pooled from three pivotal trials of the IVIG products Gammaplex 5% and Gammaplex 10%, (immune globulin intravenous [human], Bio Products Laboratory, Elstree, UK) for the treatment of PI. Characteristics of the pooled trials (This retrospective pooled analysis did n... | PMC9932595 | ||
Statistical analysis | migraine, headaches, headache, migraines | ADVERSE EVENT, ADVERSE EVENT, MIGRAINES, MIGRAINE, EVENTS | Infusion and adverse event data were pooled across three Gammaplex studies (GMX01, GMX04, GMX07). Summaries of infusion protocol were generated to identify the proportion of infusions following the 15-minute rate escalation protocol and reaching the maximum infusion rate. Adverse events were documented based on direct ... | PMC9932595 |
Infusion rate | In all trials, infusion of the IVIG product was started at an initial infusion rate for 15 minutes (0.01 mL/kg/min for the IVIG 5% formulation, 0.005 mL/kg/min for the IVIG 10% formulation), then advanced every 15 minutes if tolerated to a maximum of 0.08 mL/kg/min, using the protocols shown in Infusion rate protocols ... | PMC9932595 | ||
Results | XLA, CVID | PRIMARY IMMUNODEFICIENCY, X-LINKED AGAMMAGLOBULINEMIA, DISEASE, COMMON VARIABLE IMMUNODEFICIENCY, CVID, DISEASE | The analysis included all Gammaplex infusions administered during the PI clinical trials (1482 infusions administered to 123 patients). Of these, 1234 infusions of the 5% IVIG formulation were administered to 108 patients and 248 infusions of the 10% IVIG formulation were administered to 47 patients. Both adult and ped... | PMC9932595 |
Achievement of the maximum infusion rate | The maximum infusion rate was achieved in 94.6% (1402/1482) of infusions (Percentage of infusions in which the maximum infusion rate was achieved, by subgroup. | PMC9932595 | ||
Percentage of infusions with reported product-related headache or migraine | migraine, headache | MIGRAINE | Product-related, infusion-associated headache was reported in 6.1% (90/1482) of all infusions (Percentage of infusions associated with product-related headache or migraine by subgroup.In the age-by-product breakdown, the percentage of infusions with at least one product-related, infusion-associated headache was similar... | PMC9932595 |
Percentage of patients reporting at least one product-related headache or migraine | migraine, Headache, headache, migraines | MIGRAINE, MIGRAINES | Headache and migraine were reported by 28.5% (35/123) and 4.1% (5/123) patients, respectively. The percentage of patients reporting at least one product-related headache was similar for adults and pediatric patients (28.0% [23/82] vs 29.3% [12/41], The percentage of patients reporting at least one headache was lower fo... | PMC9932595 |
Timing of headache and migraine events | migraine, headache | MIGRAINE, EVENTS | Most headache events (77%, 96/125) and all migraine events (100%, 7/7) occurred within 72 hours of the start of the infusion (Timing of migraine and headache relative to the start of the infusion.Incidence of product-related headache and migraine by infusion number, number of events | PMC9932595 |
Discussion | migraine, Headache, IVIG-related headache, headache | MIGRAINE, ADVERSE EVENT | Headache is clearly associated with IVIG therapy for PI, but not with PI itself. In this retrospective analysis, we analyzed pooled data from three clinical trials of a single IVIG agent to confirm and extend our understanding of headache and migraine associated with IVIG infusions. Our analysis provides a systematic e... | PMC9932595 |
Data availability statement | The datasets presented in this article are not readily available because the datasets generated during and/or analyzed during the current study are not publicly available because they containing information that could compromise research participant privacy/consent. Reasonable requests as appropriate and permissible wi... | PMC9932595 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the institutional review board/ethics committee at each study center. The 3 trials each involved multiple centers. Participants from the included studies agreed to have their results published. Written informed consent to participate in this study w... | PMC9932595 | ||
Author contributions | EW, KC, and BG contributed substantially to data collection, analysis, manuscript writing, and editing. ME conducted data analysis. All authors contributed to the manuscript and approved the submitted version. | PMC9932595 | ||
Acknowledgments | K. Baldwin | Medical writing and editorial support was provided by Medical Leverage, Edward K. Baldwin, PhD and Luiza Erthal, PhD. | PMC9932595 | |
Conflict of interest | EW and KC are employees of Bio Products Laboratory. ME is an employee of Atlantic Research Group, which contracted with Bio Products Laboratory to perform the data analysis for the study. BG is a consultant for BPL; a speaker and consultant for Takeda; a speaker and consultant for Grifols; a consultant for Koru; a cons... | PMC9932595 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9932595 | ||
References | PMC9932595 | |||
Background: | Obesity, obesity | OBESITY, OBESITY, DISEASES, INFLAMMATORY DISEASE | Obesity is classified as a low-grade chronic and systemic inflammatory disease and results from complicated interactions between genes and environmental factors, which leads to many diseases and affects the quality of life. There are growing interests in the effectiveness of probiotics as a supplementation to reduce ob... | PMC10118337 |
Methods: | obese, ®, Saudi overweight | OBESE | Ninety adult Saudi overweight or obese adult will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics “MCP® BCMC® strains” for 12 weeks in a double-blind study. Biochemical markers will be measured through blood samples analyzed. Measurements and samples will be obtained at baseline... | PMC10118337 |
Discussion: | This study expects that the multi-strain probiotic product will induce beneficial changes in gut microbiota (GM) including reduction in weight, especially the visceral fat, which leads to reduction in systemic inflammatory state associated with fat accumulation. | PMC10118337 | ||
1. Introduction | obesity, obese, overweight, human obesity | OBESITY, OBESE | The incidence of obesity has increased to be a major health concern in the twenty-first century. According to the World Health Organization, 39% of adults ages 18 years and over were overweight in 2016, and 13% were obese.Confirmed data in humans have shown an association between obesity and the gut microbial community... | PMC10118337 |
1.1. Aim of the study | obese, overweight | OBESE | Study the anti-obesity effect of consuming multi-strain probiotic supplementation on overweight and obese adults. | PMC10118337 |
1.2. Objectives | Evaluate the anti-obesity effect of multi-Strain probiotic supplementation.Investigate the effect of probiotics on reducing Lipopolysaccharides LPS.Determine the effect of probiotics on liver functions.Study the association between probiotics and food intake.Evaluate the role of gender difference in response to probiot... | PMC10118337 | ||
2. Methods | gastrointestinal surgery, overweight or first-class obese | THYROID DISORDERS, RECRUITMENT, DISEASES, IMMUNE SYSTEM DISEASES | The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial to be conducted at the occupational clinical of King Saud University Medical City, Riyadh, Saudi Arabia. Recruitment of subjects will be opened for all students and employees who from King Saud University. The study link will b... | PMC10118337 |
2.1. Intervention | overweight or first-class obese | The study is a 12-week, double-blind, randomized, placebo-controlled clinical trial, 90 overweight or first-class obese subjects will be divided equally into 2 groups, a probiotics group, and a placebo group. A hypocaloric diet will be applied for both groups. Interventions will be performed in the first week and then ... | PMC10118337 | |
2.2. Outcome measures | CREST | Medical history, including physical examination and vital signs, will be recorded before inclusion. Assessment of food frequency consumption for most probiotic and prebiotic food in Saudi culture by using a Food Frequency Questionnaire designed especially for this study. 24-hour dietary recall, all subjects will be ask... | PMC10118337 | |
2.3. Blinding | BLIND | The identity of probiotic and control treatments will not be known to investigators, research staff, or subjects. The following study procedures will be in place to ensure double-blind administration of study treatments:Access to the randomization code will be strictly controlled.Packaging and labeling of test and cont... | PMC10118337 | |
1.2.3. Implementation. | The roles of members in allocation process:First: PI:Give a unique number for each subject.Sign subjects in blocks according to their gender, age, and BMI.Make a list of pairs and send it the inpatient pharmacy.Second: Members from inpatient pharmacy:Allocate subjects (1:1) in 2 different groups.Make the randomization ... | PMC10118337 | ||
2.4. Sample size calculation and data analysis | The power calculation was based on the results of Gomes and his colleagues who used the G-Power software (version 3.0.10) to calculate the sample size. The primary outcome in that study is the difference in WC between groups. The power calculation requires 17 subjects in each group (95% power; 5% type I error) to detec... | PMC10118337 | ||
3. Discussion and conclusion | obesity, overweight, weight loss, diabetes | OBESITY, OBESE, CHRONIC DISEASES, INSULIN SENSITIVITY, DIABETES | There is a growing interest in the effectiveness of probiotics for treating chronic diseases. This study will evaluate the effects of multi-strain probiotics as an anti-obesity among overweight and obese Saudi adults. Regulating microbiota is considered a potential therapeutic avenue for obesity through many different ... | PMC10118337 |
Acknowledgments | The authors acknowledge the research coordinators who are currently supporting the conduct of this trial. | PMC10118337 |
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