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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