Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062414) titled 'Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement' on Aug. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Apo Plus Station Co., Ltd.

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the body fat-reducing effect of continued consumption of the test food in conjunction with dietary improvement in obese (Class I obesity) adult men and women aged 20 to 64 years. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants in the test food group will receive dietary improvement guidance and consume the test food for 12 weeks. Interventions/Control_2 - Participants in the control food group will receive dietary improvement guidance and consume the control food for 12 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Male or female adults who are 20 years of age or older at the time of obtaining informed consent and younger than 65 years of age at the end of the intake period. (2) Individuals with a BMI of >=25.0 kg/m2 and =400 mL whole blood within 12 weeks before study initiation. (6) Females who donated >=400 mL whole blood within 16 weeks before study initiation. (7) Males whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 1,200 mL. (8) Females whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 800 mL. (9) Individuals currently participating in, recently completing, or planning to participate in another clinical study. (10) Individuals with irregular lifestyles, including shift workers. (11) Individuals with excessive alcohol consumption. (12) Individuals smoking >=21 cigarettes/day. (13) Individuals unable to consume the study foods as instructed. (14) Individuals unable to record dietary intake using the designated mobile application. (15) Regular users of FOSHU, FFC, supplements, or other health foods that may affect study outcomes. (16) Individuals regularly taking medications that may affect study outcomes. (17) Individuals expecting major lifestyle changes during the study. (18) Individuals with: a) Cardiac, hepatic, or renal disease. b) Respiratory disease. c) A history of cardiovascular disease. d) Diabetes mellitus. e) Allergies to the study foods. (19) Individuals judged ineligible by the Principal Investigator or Sub-Investigator. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 27 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 08 Month 09 Day Last follow-up date - 2027 Year 01 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071427

Disclaimer: Curated by HT Syndication.