Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062569) titled 'Effects of Continuous Soy Protein Intake on Body Composition' on Aug. 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Fuji Oil Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the effects of 12-week continuous intake of a soy protein on waist circumference and body composition in healthy adults with a BMI of 25.0 to = Gender - Male and Female Key inclusion criteria - 1)Men and women aged 20 to 49 years at the time of obtaining informed consent 2)Individuals with a BMI of 25.0 to =3 times/week of medications affecting the intestinal environment (laxatives, intestinal regulators, etc.) or foods (yogurt, lactic acid bacteria beverages, fermented foods, oligosaccharides, sugar alcohols, high-fiber foods/supplements). 7)Food allergy to the study food (soy). 8)Pregnant, lactating, or possibly pregnant during the study. 9)Excessive exercise, alcohol (>20 g pure alcohol/day, >=3 times/week), or smoking (>=21 cigarettes/day). 10)Suspected infection on virological/immunoserological tests at screening. 11)Body weight change of >=+/-5 kg within 3 months before screening. 12)Special dietary management for weight loss, or major increase in exercise, within 3 months before screening. 13)Extremely irregular lifestyle or diet (including night-shift workers). 14)Lifestyle expected to change substantially during the study. 15)Antibiotic use within 1 month before consent, or planned during the study. 16)Participation in another clinical trial within 1 month before consent, currently, or planned during the study. 17)Overseas travel planned during the study. 18)Judged unsuitable based on background survey responses. 19)Otherwise judged unsuitable by the principal or sub-investigator. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 10 Day Date of IRB - 2026 Year 08 Month 10 Day Anticipated trial start date - 2026 Year 09 Month 10 Day Last follow-up date - 2027 Year 01 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071564

Disclaimer: Curated by HT Syndication.