Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062121) titled 'A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction' on July 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill Carenet, Inc.

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

Objective: Narrative objectives1 - To investigate the effects of 12-week continuous intake of a test food on abdominal fat area (especially visceral fat area) through a randomized, double-blind, placebo-controlled, parallel-group comparison study in healthy Japanese adult men and women with a BMI of 25 kg/m^2 or more and less than 30 kg/m^2. In addition, low-dose and high-dose groups are established to evaluate dose-dependent effects and safety. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Test food 1 group (Low dose): Participants take 3 capsules containing a low dose of Sudachi peel extract powder once daily for 12 weeks. Interventions/Control_2 - Test food 2 group (High dose): Participants take 3 capsules containing a high dose of Sudachi peel extract powder once daily for 12 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Individuals aged between 20 and 64 years at the time of obtaining informed consent. 2.Healthy Japanese men and women. 3.Individuals with a BMI of 25 kg/m^2 or more and less than 30 kg/m^2 at the time of screening 4.Individuals who have the capacity to consent, have received sufficient explanation regarding the purpose and content of the study, have fully understood the information, and voluntarily agreed to participate by providing written informed consent. Key exclusion criteria - 1.Current/planned weight-loss treatment, counseling, or medication (incl. self-pay care) by a physician. 2.Current/past 6-month use of drugs affecting weight, body/visceral fat, glucose/lipid metabolism (e.g., hypoglycemics, glucocorticoids, GLP-1 agonists, SGLT2 inhibitors, anti-obesity/antidiabetic drugs, dyslipidemia agents). 3.History of serious cerebrovascular, heart, liver, kidney, blood, or endocrine disease. 4.History of major gastrointestinal surgery (e.g., gastrectomy, resection; excl. appendectomy). 5.Weight change +/-3 kg within the past 3 months. 6.Risk of allergic reaction to the test food. 7.Significant abnormalities in vital signs, physical exams, or blood tests at screening. 8.History of feeling unwell or worsening condition due to blood sampling. 9.Potential difficulties ensuring safety in CT scanning or image analysis. 10.Planned gastric X-ray (barium meal) from 2 weeks before to the end of the examination. 11.Blood donation within screening: 200mL whole (4 weeks), component (2 weeks); 400mL whole (females: 16 weeks, males: 12 weeks). 12.Unable to stop FOSHU, Foods with Function Claims, or supplements affecting weight, fat, or glucose/lipid metabolism during the study. 13.Planned new diet, exercise, training, aesthetics, or medical procedures for weight/fat loss or muscle gain during the study. 14.Current smokers. 15.Habitual alcohol drinkers. 16.Extremely irregular sleep or dietary habits. 17.Likely significant changes in living environment, diet, or exercise during the study. 18.Lactating, pregnant, possibly pregnant, or planning pregnancy during the study. 19.Participation in other clinical studies currently, within 4 weeks prior to screening, or planned during the study. 20.Otherwise judged ineligible by the principal investigator. Target Size - 99

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 25 Day Last follow-up date - 2026 Year 12 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071084

Disclaimer: Curated by HT Syndication.