Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060303) titled 'Effects of consumption of the test food on physical function in healthy Japanese' on Jan. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - OSAKA SODA CO., LTD.

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. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Lactic acid bacteria-containing food Exercise intervention: Perform resistance squat exercises equivalent to approximately 3.5 METs, 4 to 5 times per week (3 sets of 10 repetitions). Administration: Consume one tablet per day in the morning. *If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: 12 weeks Test product: Placebo food Exercise intervention: Perform resistance squat exercises equivalent to approximately 3.5 METs, 4 to 5 times per week (3 sets of 10 repetitions). Administration: Consume one tablet per day in the morning. *If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 60 years-old =2 times per week, for >= 30 minutes per session, and continuing for >= 1 year)

6. Individuals with a short walking distance in the 6-minute walk test 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 medications (including herbal medicines) or supplements

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

7. Individuals who experience pain while walking

8. Individuals who are unable to perform squats

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

10. 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

11. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 10 Day Date of IRB - 2025 Year 12 Month 10 Day Anticipated trial start date - 2026 Year 01 Month 08 Day Last follow-up date - 2026 Year 07 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068979

Disclaimer: Curated by HT Syndication.