Clinical Trial: A Study on the Effects of the Test Food on Visceral fat Reduction -A Randomized, Double-blind, Placebo-controlled Parallel-group Study- (Japan)

Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059614) titled 'A Study on the Effects of the Test Food on Visceral Fat Reduction -A Randomized, Double-blind, Placebo-controlled Parallel-group Study' on Nov. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - KSO Corporation

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

Objective: Narrative objectives1 - To examine the effects of continuous 12-week intake of the test food on abdominal visceral fat reduction in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food (1 pack a day, 12 weeks) Interventions/Control_2 - Consumption of the placebo food (1 pack a day, 12 weeks)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy subjects aged of 20-64 years 2) Subjects whose BMI is 25 kg/m2 or more and less than 30 kg/m2 at first screening test 3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing Key exclusion criteria - 1) Subjects who use habitually medications (including intestinal regulators and laxatives. However, subjects who can stop taking intestinal regulators from the first screening test until the end of this study are permitted.) 2) Subjects who have a current history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease (excluding transient treatment such as colds) 3) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis) 4) Subjects who have a history or current medical history of drug dependence or alcoholism 5) Subjects who have been diagnosed with familial hyperlipidemia 6) Subjects who are diagnosed with chronic constipation 7) Subjects who are unable to stop taking health foods and supplements (including foods for specified health uses and foods with functional claims) that may affect this study 8) Subjects who have a habit of drinking excessively (drinking more than 20 g of pure alcohol equivalent per day, at least 4 days a week) 9) Subjects who have a habit of smoking excessively (smokers of 21 cigarettes or more per day) 10) Subjects who are wearing a medical device necessary for life support, such as a cardiac pacemaker, implantable cardioverter defibrillator, or biological information monitor 11) Subjects who have a contagious disease or an injury to the palms or the soles of the feet 12) Subjects who have metal in the CT scan measurement site due to surgery, etc. 13) Subjects who are claustrophobic 14) Subjects who have reported that they are allergic to the ingredient in test foods 15) Subjects who have extremely irregular eating habits, shift workers (excluding daytime shift work), or late-night workers Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 09 Day Date of IRB - 2025 Year 08 Month 21 Day Anticipated trial start date - 2025 Year 10 Month 14 Day Last follow-up date - 2026 Year 04 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068164

Disclaimer: Curated by HT Syndication.