Tokyo, Dec. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060053) titled 'Anti-obesity study: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Dec. 11.

Study Type: Interventional

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

Primary Sponsor: Institute - UNIAL Co., Ltd.

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

Objective: Narrative objectives1 - To verify the anti-obesity effects of the test food. Basic objectives2 - Safety,Efficacy

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

Eligibility: Age-lower limit - 18 years-old = 23 kg/m2 and < 30 kg/m2 at screening

6. Individuals with a large abdominal visceral fat area at screening 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, particularly those with iodine allergy

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

8. 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

9. 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 - 2025 Year 11 Month 26 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2025 Year 12 Month 11 Day Last follow-up date - 2026 Year 06 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068673

Disclaimer: Curated by HT Syndication.