Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059534) titled 'Evaluation of the effects of test foods on motor function' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - EP Mediate Co., Ltd.

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and efficacy of the test food in improving motor function after 8 weeks of daily intake, using a placebo as a control. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Supplementation of the test food and exercise over a period of 8 weeks. Interventions/Control_2 - Supplementation of placebo and exercise over a period of 8 weeks.

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy males and females from 50 to 75 years of age (2) Person who can understand the purpose and content of this study and agree in this study Key exclusion criteria - (1)Subjects who clearly have low percent of body fat. (2)Subjects who cannot do prescribed resistance exercise. (3)Subjects who cannot take in the supplement. (4)Subjects who are chronic conditions who regularly take medication. (5)Subjects who are suffering from mental disorders, sleep disorders, heart disease, kidney disease, diabetes, or other serious illnesses or metabolic disorders. (6)With a history of severe illness who the principal investigator determines to be unsuitable for study participation. (7)With serious current or past medical conditions such as cerebrovascular disease, malignant tumors, immune disorders, thyroid disorders, adrenal disorders, or other metabolic disorders. (8)Subjects who have experienced dizziness, fainting, or transient visual loss, and for whom the principal investigator has determined participation in the study would be problematic. (9) Subjects who are treat menopausal disorders. (10) Subjects with are musculoskeletal disorders that restrict physical activity. (11) Subjects who are taking medication that affects heart rate. (12) Subjects who may develop allergies in relation to the study. (13) Subjects regularly taking pharmaceuticals, quasi-drugs, Kampo medicines, health foods, or over-the-counter drugs, foods for specified health uses, foods with functional claims, nutritional functional foods, etc., that may affect research. (14) Subjects who regularly consumed health supplements that could potentially affect body fat or muscle function within the three months prior to obtaining consent, or who plan to consume such supplements during the study period. (15) Shift workers whose shifts extend past midnight or night shift workers. (16) Subjects with extremely intense exercise habits. (17) Subjects whose systolic blood pressure is less than 90mmHg. (18)Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 23 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 10 Month 27 Day Last follow-up date - 2026 Year 02 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068096

Disclaimer: Curated by HT Syndication.