Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058102) titled 'Effects of long-term consumption of the test food on muscle in healthy Japanese' on Aug. 27.

Study Type: Interventional

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

Primary Sponsor: Institute - Nakahara Co., Ltd.

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

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

Intervention: Interventions/Control_1 - Duration: 48 weeks Test product: Test food Interventions/Control_2 - Duration: 48 weeks Test product: Test food

*After 24 weeks of intervention (from day 169 of intervention to the day before 48-week post-intervention examination), the test product will not be taken.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged between 40 and 64

4. Healthy individuals

5. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

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 who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

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

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals who usually take high-protein beverages

8. Individuals who are restricting their diets or exercising for the purpose of dieting

9. Individuals who are exercising for muscle building at training gyms or similar facilities

10. Individuals who are pregnant, lactating, or planning to become pregnant during this study

11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

12. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 05 Month 28 Day Date of IRB - 2025 Year 05 Month 28 Day Anticipated trial start date - 2025 Year 06 Month 06 Day Last follow-up date - 2026 Year 08 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066389

Disclaimer: Curated by HT Syndication.