Tokyo, Jan. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060257) titled 'Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study' on Jan. 14.

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 of 8 weeks ingestion of polyphenol on body composition in a randomized, double-blind, placebo-controlled, parallel group study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consume the test food once a day for 8 weeks. Interventions/Control_2 - Consume the placebo food once a day for 8 weeks.

Eligibility: Age-lower limit - 40 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.Those who are continuously using oral, injectable, or other systemic medications for the treatment of chronic diseases. 2.Those who are under medical supervision for exercise therapy or dietary therapy. 3.Those with HbA1c levels of 6.5% or more at the time of screening. 4.Those who use implantable metallic medical devices. 5.Those with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring official reports. 6.Those with major surgical history related to the digestive system. 7.Those with seriously abnormal blood pressure, physical data or hematologic data. 8.Those with severe anemia. 9.Pre- or post-menopausal women with obvious physical changes. 10.Those who may have allergic reactions to drugs, foods. 11.Those with high sensitivity to caffeine. 12.Those who regularly use medications, dietary supplements, foods for specified health uses, or foods with function claims that affect body weight or body fat. 13.Those who frequently take polyphenol-rich foods. 14.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 15.Those who are unable to stop taking dietary supplements and foods with health claims during the study. 16.Those whose lifestyle is planned to change during the study. 17.Those who plan to transfer, or take a business trip or travel for one week or longer during the study. 18.Those who changes in body weight of 10% or more within 12 wks prior to the screening. 19.Those 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. 20.Pregnant or lactating women or those planning to become pregnant. 21.Those who currently participate in other clinical trials or participated within the last 4 wks prior to the current study. 22.Those ineligible due to physician's judgment. Target Size - 44

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 22 Day Date of IRB - 2025 Year 12 Month 22 Day Anticipated trial start date - 2026 Year 01 Month 21 Day Last follow-up date - 2026 Year 06 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068921

Disclaimer: Curated by HT Syndication.