Tokyo, May 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061655) titled 'Effects of consumption of the test food on body fat in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on May 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Yotsuba Milk Products 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 the body fat in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Capsule containing Lentilactobacillus kefiri YRC2606 powder Administration: Take one capsule with water without chewing per day.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: 12 weeks Test product: Capsule not containing Lentilactobacillus kefiri YRC2606 powder Administration: Take one capsule with water without chewing per day.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Eligibility: Age-lower limit - 18 years-old = 23 kg/m2 and < 30 kg/m2 at Scr 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 are pregnant, lactating, or planning to become pregnant during this study

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

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 13 Day Date of IRB - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 05 Month 22 Day Last follow-up date - 2026 Year 10 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070544

Disclaimer: Curated by HT Syndication.