Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062093) titled 'Effects of consumption of the test food on skeletal muscle in healthy Japanese' on June 29.

Study Type: Interventional

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

Primary Sponsor: Institute - J-OIL MILLS, Inc.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on skeletal muscle in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Food Interventions/Control_2 - Duration: 12 weeks Test product: Placebo food

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged 50 or more

4. Healthy individuals

5. Individuals who have low scoring of lower-body extension strength at screening Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals diagnosed with sarcopenia or frailty

5. Individuals with a history of conditions or diseases that could potentially affect the assessment of lower limb muscle strength

6. Individuals who engage in at least 60 minutes of exercise per week that elevates their heart rate and causes them to sweat

7. Individuals who engage in strength training (including bodyweight exercises such as push-ups) or activities such as running, walking, cycling, or swimming at least twice a week

8. Individuals who are a smoker

9. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

10. Individuals who are taking or using medications (including herbal medicines) or supplements

11. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day

12. Individuals who take dairy products such as milk and cheese at least four times a week

13. Individuals who are allergic to medications or foods related to the test food (particularly gelatin)

14. Individuals who are pregnant, lactating, or planning pregnancy during this study

15. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 05 Month 27 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2026 Year 12 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071046

Disclaimer: Curated by HT Syndication.