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2.2. Participants | pain | MAY | Healthy Japanese participants with mild pain of the knee joint(s) were recruited from 18 May 2021 to 21 August 2021, by Ortho Medico (Tokyo, Japan), a contracted research organization, using a website ( | PMC10346176 |
2.3. Study Design | knee pain | This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to two groups, namely, an MSM consumption group and a placebo control group, with a 1:1 ratio. The details of this study were explained, and written informed consent was obtained from all participants. Both groups o... | PMC10346176 | |
2.4. Outcomes | SECONDARY | The measured values of the total score of JKOM at 12 weeks after the test sample consumption were considered the primary outcome of this study. The secondary outcomes were as follows: (1) the measured values of the total score of JKOM at 4 and 8 weeks after consumption; (2) the differences in the total score of JKOM be... | PMC10346176 | |
2.5. Sample Size and Statistical Analysis | Kawasaki | KAWASAKI | The target sample size was 80, assuming an ineligibility rate of approximately 10%. The sample size was calculated with the following assumptions: Cohen’s d = 0.80, type I error rate = 0.05, power = 80%, and the ratio of the two groups = 1:1. All participants, physicians, investigators, and analysts were blinded to the... | PMC10346176 |
3. Results | PMC10346176 | |||
3.1. Participant Flow | pain | MAY | From 25 May 2021 to 21 August 2021, 163 healthy Japanese participants with mild pain of the knee joint(s) were screened for enrollment ( | PMC10346176 |
3.2. JKOM Scores, JOA Scores, and Inflammation Markers | The measured values of JKOM scores and JOA scores are shown in The results of inflammatory markers and type II collagen biomarkers are shown in | PMC10346176 | ||
3.3. Questionaries | pain | The JKOM questionnaire consists of a total of 25 items: Q1 to Q8 for pain and stiffness in knees, Q9 to Q18 for conditions in daily life, Q19 to Q23 for general activities, and Q24 to Q25 for health conditions. Answers for each question were chosen from a scale of 0 to 4: 0 for no pain at all or good condition, and 4 f... | PMC10346176 | |
3.4. Safety Evaluation | ADVERSE EVENTS | The results of physical examination, urine analysis, peripheral blood test, and medical interview revealed no health problems during the study period, and no adverse events were reported ( | PMC10346176 | |
4. Discussion | Depressive, comorbidity, OA, inflammation, morning pain, KOA, pain, knee pain | OBESE, INFLAMMATION, DEGENERATIVE, PATHOPHYSIOLOGY, OXIDATIVE STRESS | This is the first clinical trial of MSM oral consumption in healthy participants who felt mild pain in the knee joint rather than patients with OA. The JKOM total scores at 12 weeks after test sample consumption in the MSM group were significantly lower than those in the placebo group. The health conditions of the JKOM... | PMC10346176 |
5. Conclusions | pain | This study indicated that MSM oral consumption improved knee conditions and systemic health conditions in healthy participants who were experiencing mild pain in the knee joint. | PMC10346176 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10346176 | ||
Author Contributions | A.T. and N.N. conceived and designed the study. A.T., N.N. and A.Y. analyzed the data and drafted the manuscript. T.K. and A.Y. supervised the study. All authors have read and agreed to the published version of the manuscript. | PMC10346176 | ||
Institutional Review Board Statement | This study was conducted in accordance with the principles of the Declaration of Helsinki. The trial protocol and any amendments were approved by the ethics committee of the Takara Clinic, Medical Corporation Seishinkai (approval number: 2204-00145-0004-0E-TC), and statistical analysis was performed by Ortho Medico. Th... | PMC10346176 | ||
Informed Consent Statement | Informed consent was obtained from all patients involved in this study. | PMC10346176 | ||
Data Availability Statement | The data used to support the findings of this study are available from the corresponding author upon reasonable request. | PMC10346176 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10346176 | ||
References | KNEE OSTEOARTHRITIS | Consort flow diagram.Effect of MSM consumption on JKOM questions. (Background of the study participants.PPS, Per protocol set; SAF, Safety analysis population; Japanese Knee Osteoarthritis Measure (JKOM) and Japanese Orthopaedic Association (JOA) scores from weeks 0 to 12.CI, confidence interval; Plasma concentrations ... | PMC10346176 | |
1. Introduction | obesity, muscle mass, weight gain, overweight, mitochondrial dysfunction, weight loss | OBESITY, OBESE, INFLAMMATION, MITOCHONDRIAL DYSFUNCTION, OXIDATIVE STRESS, PATHOGENESIS | Background: Despite the growing recognition of the obesity crisis, its rates continue to rise. The current first-line therapies, such as dietary changes, energy restriction, and physical activity, are typically met with poor adherence. Novel nutritional interventions can address the root causes of obesity, including mi... | PMC10490028 |
2. Materials and Methods | PMC10490028 | |||
2.1. Participant Screening & Recruitment | overweight, Overweight | OBESE | Overweight and obese men and women were recruited for the current study. Potential participants were first screened by email or telephone to confirm that they were a male or female between the ages 18 and 50 y, were overweight (BMI 25–29.9 kg/m | PMC10490028 |
2.2. Experimental Design | Participants were randomly allocated to receive either the multi-ingredient nutritional supplement (MIS) consisting of 7 ingredients (The following assessments were performed on eligible participants at the initiation of the study and after completion of the 12 wk supplement period: DXA scan, blood pressure, antecubita... | PMC10490028 | ||
2.3. Nutritional Supplementation | The exact composition of and nutrition information for the MIS and PLA capsules is provided in | PMC10490028 | ||
2.4. Anthropometric Measurements and Body Composition | Participants were weighed at baseline and at each follow-up study visit. Weight was measured using a Health-O-Meter 2600KL Digital Wheelchair Scale (Pelstar, McCook, IL, USA), and height was measured using a stadiometer (Perspective Enterprises, Portage, MI, USA). Waist and measurements for the calculation of WHR [ | PMC10490028 | ||
2.5. Measurement of Blood Pressure | Participants were fitted with a FlexiPort™ reusable blood pressure cuff (WelchAllyn, Inc., Okumoto, NY, USA) to measure blood pressure while the participant was relaxed and seated for 15 min. Measurements were obtained with an automated blood pressure machine (Spot Vital Signs Device, WelchAllyn). | PMC10490028 | ||
2.6. Venous Blood Sampling and Analysis | dyslipidemia | BLOOD, INSULIN RESISTANCE, DYSLIPIDEMIA | Blood was collected in the morning following an overnight 10 h fast (no food or caffeine) and the participants were instructed to consume 250 mL of water prior to arrival. Blood was taken from the antecubital vein and drawn into evacuated tubes with heparin for plasma collection, ethylenediaminetetraacetic acid (EDTA) ... | PMC10490028 |
2.7. Isolation of Extracellular Vesicles | Exactly 400 µL of serum was initially subjected to two consecutive centrifugation spins at 2000× | PMC10490028 | ||
2.8. miRNA Extraction and RT-PCR | The MagMAX™ | PMC10490028 | ||
2.9. Metabolic Measures and Resting Metabolic Rate (RMR) | Participants were placed in a supine position while connected to a metabolic cart with an online gas collection system (Moxus Modular Oxygen Uptake System, AEI Technologies, Pittsburgh, PA, USA), and the system acquired oxygen consumption (VO | PMC10490028 | ||
2.10. Maximal Voluntary VO | Participants completed a double-leg incremental peak oxygen uptake (VO | PMC10490028 | ||
2.11. Maximal Voluntary Handgrip Assessment | Handgrip strength was measured using an isometric dynamometer (JAMAR | PMC10490028 | ||
2.12. Questionnaires | The RAND 36-Item Health Survey Version 1.0 is used extensively as a survey instrument for assessing participant health-related quality of life (HRQOL). We examined scales pertaining to physical functioning and role limitations due to health problems instead of the total score [ | PMC10490028 | ||
2.13. Dietary Intake | Three-day food records (recording 2 weekdays and 1 weekend day) were collected and analyzed using the MyFitnessPal smartphone app (MyFitnessPal, Under Armour, Baltimore, MD, USA.) and website that tracks diet and exercise. If participants were not comfortable with utilizing the smartphone application, they were provide... | PMC10490028 | ||
2.14. Activity Tracking | Study participants were provided with a pedometer (Omron HJ-321, Omron, Kyoto, Japan) to record their daily step counts for three separate 7 d periods within the study to determine average daily step count. Daily step count for a 7 d period was recorded at periods before the participant began the study protocol, at the... | PMC10490028 | ||
2.15. Sample Size Calculation | The MIS was comprised of 7 separate ingredients, with aspects featuring a potential varied or synergistic [ | PMC10490028 | ||
2.16. Statistical Analysis | Post-intervention differences between treatment arms in outcome variables were compared using a one-way analysis of covariance (ANCOVA), implementing the corresponding pre-intervention variables as covariates. If data were not normally distributed, logarithmic transformations were performed. Endpoints that were intract... | PMC10490028 | ||
3. Results | PMC10490028 | |||
3.1. Study Information and Compliance | A total of 65 participants were randomized: 55 completed the study, five dropped out ( | PMC10490028 | ||
3.2. Baseline Characteristics | overweight | OBESE | Fifty-five participants (23 men, 32 women) with a mean age of 25.9 ± 1.1 y (mean ± SEM) completed the study. The participants were overweight to obese, with a mean BMI of 30.5 ± 0.6 kg/m | PMC10490028 |
3.3. Co-Primary Outcomes Utilizing Modified ITT | For the examination of weight and fat mass (co-primary outcomes) exclusively, we utilized a modified ITT analysis. After adjustment for pre-intervention body weight, there was a statistically significant difference in post-intervention body weight between the PLA and MIS interventions, | PMC10490028 | ||
3.4. Anthropometry and Body Composition | After adjustment for pre-intervention body weight, there was a statistically significant difference in post-intervention weight between the treatment arms (After adjustment for pre-intervention fat mass, there was a significant difference in post-intervention fat mass between the treatment arms (There was no significan... | PMC10490028 | ||
3.5. Clinical Biochemistry | Following adjustment for pre-intervention ALT, there was a significant difference in post-intervention ALT between the treatment arms (Following adjustment for the respective baseline variables, there were no significant differences in post-intervention serum creatinine (There were no significant differences between th... | PMC10490028 | ||
3.6. Markers of Dyslipidemia and Glucose Metabolism | There were no significant differences between the treatment arms with respect to total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), and triglycerides ( | PMC10490028 | ||
3.7. Hematology | After adjustment for pre-intervention circulating eosinophil cell population, there was a statistically significant difference in post-intervention data between the treatment arms ( | PMC10490028 | ||
3.8. Indices of Physical Health, Metabolism and Function | No statistically significant differences were found between the two treatment arms in post-intervention systolic blood pressure, diastolic blood pressure, resting heart rate, or bone mineral density, adjusted for the corresponding pre-intervention variable data ( | PMC10490028 | ||
3.9. Diet, Activity Level, and Self-Reported Quality of Life | At baseline, there was no significant difference between the treatment arms in terms of energy intake, caffeine consumption, and 7-day pedometer-derived average daily step count ( | PMC10490028 | ||
3.10. Molecular Signalling Factors and Antioxidant Capacity | EV-associated | Post-intervention growth differentiation factor 15 (GDF15) was significantly different between the two treatment arms, following adjustment for pre-intervention data (The circulating EV-associated miRNA species miR-34a (Oxygen Radical Absorbance Capacity (ORAC) within the blood plasma was not significantly different th... | PMC10490028 | |
4. Discussion | obesity, liver disease, obesity-related glomerulopathy, Fatty liver disease, overweight, mitochondrial dysfunction, weight loss, impairment of kidney function | OBESITY, OBESE, LIVER DISEASE, MITOCHONDRIAL DYSFUNCTION, PATHOGENESIS | We report that the daily consumption of a multi-ingredient supplement (MIS) designed to facilitate weight loss and mitochondrial function [Amongst an overweight population, there is a significantly lower mortality risk for individuals who are classified as overweight (BMI of 25.0–29.9 kg/mBy design, it is not possible ... | PMC10490028 |
5. Conclusions | In conclusion, the provision of 12 wks of MIS comprising ingredients known to facilitate mitochondrial function, increase lipid metabolism, and enhance body re-composition [ | PMC10490028 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10490028 | ||
Author Contributions | J.P.N.: Conceptualization, Methodology, Validation, Formal Analysis, Investigation, Writing—Original Draft, Visualization, and Project Administration. A.J.M.: Formal Analysis, Investigation, Reviewing, and Project Administration. D.X.: Formal Analysis, Investigation, Writing, and Reviewing. A.D.C.: Formal Analysis, Inv... | PMC10490028 | ||
Institutional Review Board Statement | The study was approved by the Hamilton Health Sciences Integrated Research Ethics Board (HIREB-5754), conformed to the guidelines outlined in the Declaration of Helsinki, and complied with the guidelines set out in the Canadian Tri-Council policy statement on ethical conduct for research involving humans. The trial was... | PMC10490028 | ||
Informed Consent Statement | All participants were informed of the nature of the study and its potential risks before providing their written informed consent. | PMC10490028 | ||
Data Availability Statement | Not applicable. | PMC10490028 | ||
Conflicts of Interest | GENETIC DISORDERS, FOUNDER, CHRONIC DISEASES | Exerkine Corporation is a biotechnology company that develops and commercializes therapies based on supplements, exercise-derived factors (‘exerkines’), and extracellular vesicles to treat genetic disorders, chronic diseases, and aging. MAT is the founder, CEO, and CSO of Exerkine Corporation. At the time of publicatio... | PMC10490028 | |
References | ± SE | INFLAMMATION | Characterization of anthropometric changes following 12 wks of a multi-ingredient supplement (MIS, Characterization of plasma and circulating molecular signaling factors following 12 wks of a multi-ingredient supplement (MIS, green bars) compared to placebo (PLA, pink bars). (Characterization of plasma antioxidant cont... | PMC10490028 |
Background | Choline, as a neurotransmitter acetylcholine precursor, is reportedly associated with cognitive function. Although there are several cohort and animal studies on choline-containing foods and cognitive function, only a few interventional studies were reported. Egg yolk is a rich source of different choline-containing ch... | PMC10280906 | ||
Methods | dementia | MOS | A 12-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 41 middle-aged and elderly males and females (43.9% female) aged ≥ 60 years and ≤ 80 years without dementia. Participants were randomly assigned to placebo and choline groups. The choline group received a supplement containin... | PMC10280906 |
Results | The change amount of verbal memory scores and verbal memory test-correct hit (delay) was significantly higher in the choline group than in the placebo group at baseline-6 and baseline-12 weeks. The plasma free choline level was significantly higher in the choline group compared with the placebo group at 6 weeks. Conver... | PMC10280906 | ||
Conclusions | The results suggested that continued 300 mg/day intake of egg yolk choline improved verbal memory, which is a part of cognitive functions. To confirm the observed effects of egg yolk choline, more well-designed and large-scale studies are warranted. | PMC10280906 | ||
Trial registration | Study protocols were pre-registered in the Clinical Trials Registration System (UMIN-CTR) (UMIN 000045050). | PMC10280906 | ||
Keywords | PMC10280906 | |||
Background | forgetfulness, dementia | Recently, population aging has progressed worldwide. The number of people aged ≥ 60 years is expected to increase by 2 billion till 2050 [Exercise habituation, smoking cessation, nutritional intervention, and social activity are recommended to reduce the risk of developing dementia [PC, one of the choline compound in t... | PMC10280906 | |
Methods | PMC10280906 | |||
Subjects | forgetfulness, dementia, ill | The participants were 60 middle-aged and elderly Japanese males and females aged 60–80 years without dementia who had been made aware of their forgetfulness or had it pointed out by others. Moreover, they were judged not to be ill by a clinical investigator and with 26 points or more on the Mini-Mental State Examinatio... | PMC10280906 | |
Study design | The study was conducted at KSO Inc. (Tokyo, Japan) from August to December 2021, under the supervision of Iwama Y. as the principal investigator with support from a project team composed of a doctor, a clinical laboratory technician, and a nutritionist. This 12-week, randomized, double-blind, placebo-controlled, parall... | PMC10280906 | ||
Primary endpoint | As the primary endpoint, the Cognitrax test (Health Solution Inc., Tokyo, Japan), a computer-based cognitive test with a Japanese version developed by CNS Vital Signs, LLC. (USA) [ | PMC10280906 | ||
Secondary endpoints | SECONDARY | As secondary endpoints, five tests were conducted. All tests other than safety evaluations were conducted before the test and 6 and 12 weeks after intake. Safety evaluations were conducted before the test and 12 weeks after intake. | PMC10280906 | |
Trail making test | TMT part A (TMT-A) and part B (TMT-B) were performed to assess attention and executive function. Participants were asked to connect the numbers from 1 to 25 in TMT-A and to connect the numbers from 1 to 13 and the 12 Japanese letters alternatively in TMT-B as early as possible. The time taken to perform the test and th... | PMC10280906 | ||
SF-36 | pain | SF-36 consisted of 36 questions to measure eight health concept subscales (physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). Additionally, physical component summary scores (PCS), mental component summary scores, and role/social component... | PMC10280906 | |
WHO-5 | cheerful | WHO-5 consisted of five questions (cheerful and in good spirits, calm and relaxed, active and vigorous, wake up feeling fresh and rested, things that interest me) to assess the condition in the last 2 weeks, and each score and total score were calculated. | PMC10280906 | |
Plasma choline level | Plasma free and fat-soluble choline levels were analyzed, respectively. 100 μL of plasma was mixed with 900 μL of methanol. Following sonication for 10 minutes, the samples were centrifuged at 15,000 rpm for 10 min. at 4°C, and the supernatant was aliquoted. Filter filtration was performed immediately before the analys... | PMC10280906 | ||
Dietary survey with BDHQs | overeating or undereating | This was performed to ensure that subjects were not overeating or undereating, which would negatively influence the evaluation of the effects of functional foods. | PMC10280906 | |
Safety evaluation | high-density lipoprotein-cholesterol, occult blood reaction | ADVERSE EVENTS, BLOOD | As a safety evaluation, it was performed that, physical measurement (height, weight, and body mass index), physical examination (systolic blood pressure, diastolic blood pressure, and pulse), hematological tests (leukocyte count, erythrocyte count, hematocrit, and platelet count), blood biochemistry tests (total protei... | PMC10280906 |
Ethical approval | The study was conducted after obtaining approval from the Nihonbashi Cardiology Clinic Institutional Review Board (approval number: NJI-021-07-01, approval date: July 27, 2021), in accordance with the principles of the Declaration of Helsinki by the World Medical Association and the ethical guidelines for bioscience an... | PMC10280906 | ||
Statistical analysis | Allocation-adjustment factors were age, sex, egg consumption, plasma free choline level, Cognitrax short version total and verbal memory scores, MMSE-J score, and GDS-S-J score. The reason why the verbal memory score was added to the adjustment factor is that the function was confirmed by previous research [The test re... | PMC10280906 | ||
Results | PMC10280906 | |||
Subject characteristics | SE | Participant characteristics are shown in Table Participant characteristicsMean ± SE of 20 or 21 subjects. The | PMC10280906 | |
TMT | SE | The results of the TMT scores are shown in Table Effects of egg yolk choline on ⊿TMT test scores in subjectsMean ± SE of 20 or 21 subjects. The | PMC10280906 | |
QOL survey | SF-36 revealed significantly lower PCS 12 weeks post-ingestion in the choline group compared with the placebo group (1.88 ± 1.1vs. −1.76 ± 1.19; | PMC10280906 | ||
Discussion | forgetfulness, dementia | This study evaluated the effects of continuous egg yolk choline ingestion at 300 mg on cognitive function in middle-aged and older adults who were aware of healthy forgetfulness but not dementia or who had been indicated by others for forgetfulness. The results showed that there was a significant improvement in the cho... | PMC10280906 | |
Strength and limitation | The appearance of significant differences in VBM score (at 6 weeks: In the future, to assess the effects of choline intake more accurately, dietary choline intake will need to be investigated in Japan, or intervention tests will need to be conducted in the area where choline is listed in the dietary reference intake in... | PMC10280906 | ||
Conclusions | dementia | This study showed that in middle-aged and older Japanese males and females, ingestion of 300 mg/day egg yolk choline increased plasma free choline levels and improved verbal memory, a part of cognitive function. It has been proposed that the consumption of egg yolk choline could potentially maintain cognitive function ... | PMC10280906 | |
Acknowledgements | We gratefully acknowledge the individuals who participated in this test. We also thank Enago ( | PMC10280906 | ||
Authors’ contributions | S.Y., N.K., W.W., K.S., M.K., Y.T., and R.M. conceived the study concept and design. M.K., Y.T., and R.M. as principal investigator was responsible for study logistics, data acquisition. Y.S. and N.K. prepared the manuscript. S.Y., N.K., K.S., Y.T., and Y.I. were responsible for conducting the trial, and data collectio... | PMC10280906 | ||
Funding | This research and was funded by Kewpie Corporation (Tokyo, Japan). | PMC10280906 | ||
Availability of data and materials | The dataset supporting the conclusions of this article is included within the article. | PMC10280906 | ||
Declarations | PMC10280906 | |||
Ethics approval and consent to participate | The study was conducted after obtaining approval from the Nihonbashi Cardiology Clinic Institutional Review Board (approval number: NJI-021-07-01, approval date: July 27, 2021) and registering with the University Hospital Medical Information Network (UMIN) Center, (UMIN 000045050; registration date: August 4, 2021) fol... | PMC10280906 | ||
Consent for publication | Not applicable. | PMC10280906 | ||
Competing interests | S.Y., N.K., W.W., K.S., Y.T., M.K., and R.M. are employees of Kewpie Corporation. The remaining authors have no other conflicts of interest to report in this work. | PMC10280906 | ||
References | PMC10280906 | |||
Introduction | lung cancer, cancer, Lung cancer, death | LUNG CANCER, CANCER, LUNG CANCER | Lung cancer remains the leading cause of death from cancer, worldwide. Developing early detection diagnostic methods, especially non-invasive methods, is a critical component to raising the overall survival rate and prognosis for lung cancer. The purpose of this study is to evaluate two protocols of a novel in vitro ce... | PMC9927051 |
Method | Lung cancer | BLOOD, LUNG CANCER, LUNG TUMOR | The test platform is based on changes in the metabolic pathways of the immune cells following their activation by antigenic stimuli associated with Lung cancer. Peripheral Blood Mononuclear Cells are loaded on a multiwell plate together with various lung tumor associated antigens and a fluorescent probe that exhibits a... | PMC9927051 |
Results | lung cancer stage | In the later clinical trial, an improved test protocol was applied and resulted in increased test accuracy. Specificity of the test increased to 94.0% and test sensitivity increased to 97.3% in lung cancer stage I, by using the improved protocol. | PMC9927051 | |
Conclusion | lung cancer | LUNG CANCER | The improved protocol of the novel cellular immune metabolic response based test detects stage I and stage II of lung cancer with high specificity and sensitivity, with low material costs and fast results. | PMC9927051 |
Keywords | PMC9927051 | |||
Background | cancer, Lung cancer, death, MLC | DISEASE, CANCER, LUNG CANCER | Lung cancer (LC) remains the worldwide leading cause of death from cancer. Unfortunately, approximately 75% of patients are diagnosed at an advanced stage of the disease (III, IV) [Current diagnostic methods (e.g., Computed Tomography—CT, Positron Emission Tomography—PET, Low-dose CT- LDCT, radiography) have high sensi... | PMC9927051 |
Methods | PMC9927051 | |||
Metabolic activity test | PMC9927051 |
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