Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061773) titled 'Effect of Daily Ingestion of Difructose Anhydride III (DFA III) on Visceral Fat : A Preliminary Study' on June 3.

Study Type: Interventional

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

Primary Sponsor: Institute - Hokkaido Information University

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

Objective: Narrative objectives1 - To investigate the effects and the effective dose of 16-week DFA III ingestion on visceral fat in a randomized, double-blind, placebo-controlled, parallel-group study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Daily ingestion two packets (2.5 g per packet) of test food 1 for 16 weeks. Interventions/Control_2 - Daily ingestion two packets (2.5 g per packet) of test food 2 for 16 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Those who agree to participate in this study with a written informed consent. 2. Those with BMI is >=23 kg/m2 and <30 kg/m2 at the time of screening. Key exclusion criteria - 1. Subjects who are under physician's advice, treatment, and/or medication for obese, diabetes, and/or dyslipidemia. 2. Subjects with implantable electronic medical devices. 3. Subjects who have metal implants at the CT scan site. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, endocrine diseases and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect obese and/or intestinal environment. 11. Subjects with oligosaccharide intolerance. 12. Subjects who changes in body weight of 10% or more within 12 wks prior to the screening. 13. Subjects whose lifestyle is planned to change during the study. 14. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 15. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks(men), 200 ml whole blood within 4 wks (men and women), or blood components within 2 wks (men and women), prior to the screening. 16. Pregnant or lactating women or those planning to become pregnant. 17. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator. Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 28 Day Date of IRB - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 06 Month 09 Day Last follow-up date - 2026 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070685

Disclaimer: Curated by HT Syndication.