Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062514) titled 'Anti-Obesity and Bowel Movement Improvement Effects of Food Component Intake: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study' on Aug. 7.

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 - The objective of this study is to evaluate the anti-obesity and bowel movement improvement effects of a food component intake. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Taking the test food for 12 consecutive weeks. Interventions/Control_2 - Taking the control food for 12 consecutive weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Healthy men and women aged 20 years or older and under 65 years at the time of obtaining consent 2. Individuals with a BMI of 25 or more and less than 30 at the time of screening 3. Individuals who have received sufficient explanation of the purpose and content of this study, have the capacity to consent, have fully understood it, voluntarily wish to participate, and have provided written informed consent to participate in this study Key exclusion criteria - Individuals who/with: 1. Using medications affecting obesity or bowel movements 2. Cannot discontinue FOSHU, Foods with Function Claims, or supplements affecting obesity or bowel movements 3. Have chronic diseases requiring regular medication 4. Suffering from serious liver, cardiovascular, respiratory, endocrine, metabolic disorders, or food allergies 5. History of drug or alcohol dependence 6. Metal implants in CT scan area 7. Claustrophobia interfering with CT scanning 8. Cardiac pacemakers or implantable defibrillators 9. Diagnosed with familial hyperlipidemia 10. Food allergies 11. Heavy smoking (>=21 cigarettes/day) 12. History of gastrointestinal diseases or surgery affecting digestion/absorption (excluding appendicitis) 13. Habitual alcohol consumption >20g/day on >=4 days/week 14. Extremely irregular eating habits or shift/night workers 15. Blood donation of 200mL within 1 month or >400mL/component donation within 3 months 16. Participating in or intending to join other clinical studies 17. Pregnant, lactating, or planning pregnancy during study 18. Judged inappropriate by principal investigato Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 09 Day Date of IRB - 2026 Year 07 Month 09 Day Anticipated trial start date - 2026 Year 08 Month 08 Day Last follow-up date - 2026 Year 12 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071546

Disclaimer: Curated by HT Syndication.