Clinical Trial: Effects of Daily Consumption of Steamed Miyadaizu Soybeans on Muscle Strength in Adults with Low Levels of Habitual Physical Activity: A Randomized, Open-Label, Parallel-Group Trial (Japan)

Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062896) titled 'A study of the effects of eating steamed Miyadaizu soybeans for 4 weeks on muscle strength and muscle mass in adults without regular exercise habits' on Sept. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - University of Miyazaki

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

Objective: Narrative objectives1 - To explore the effects of continuous consumption of steamed Miyadaizu soybeans on muscle strength and muscle mass in healthy adults aged 40-69 years with low levels of habitual physical activity and no regular exercise habits. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 50 g/day of steamed Miyadaizu soybeans for 4 weeks Interventions/Control_2 - No consumption of steamed Miyadaizu soybeans for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Japanese men and women aged 40-69 years at the time of informed consent. 3. Subjects classified as having low physical activity according to the international physical activity questionnaire-short form (IPAQ-SF) 4. Subjects who do not meet the definition of a regular exercise habit in the National Health and Nutrition Survey of Japan: exercise causing light sweating for at least 30 minutes per session, at least 2 days per week, for at least 1 year. 5. Subjects who have no clinical abnormality by screening tests. 6. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study. Key exclusion criteria - 1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular, dermatological, and/or mental disease, or who have history of those disease. 2. Subjects who have a serious injury or surgical history within 12weeks prior to this study. 3. Pre-or post-menopausal women having obvious changes in physical condition. 4. Subjects unable to safely undergo handgrip strength measurement, the sit-to-stand test, or body composition measurement. 5. Subjects using an implantable medical device such as a cardiac pacemaker. 6. Subjects with an allergy to soybeans or any test-food ingredient, or who cannot consume 50 g of soybeans per day. 7. Subjects who habitually used soy-derived health foods or supplements (e.g., isoflavones or equol) within the past 3 months. 8. Subjects who used drugs with anabolic effects (e.g., steroids) or protein-based health foods/supplements within the past 3 months. 9. Subjects who have continuously used antibiotics for more than 1 week within the past 3 months. 10. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 60g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 11. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study or subjects who plan to donate blood during this study. 12. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study. 13. Subjects who have cognitive disorder or who have possibility of the disorder. 14. Subjects who participate and take the study drug in other clinical trials within four weeks prior to this study. 15. Subjects who are judged as unsuitable for this study by the principal investigator or sub investigators. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 13 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 03 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071956

Disclaimer: Curated by HT Syndication.