Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063606) titled 'Evaluation of the Abdominal Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with an Exercise Intervention' on Nov. 13.

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 abdominal fat-reducing effect of continued consumption of the test food in conjunction with an exercise intervention 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 an exercise intervention and consume the test food for 12 weeks. Interventions/Control_2 - Participants in the control food group will receive an exercise intervention and consume the test 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. (5)Females who donated >=400 mL whole blood within 16 weeks before study initiation. (6)Males whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 1,200 mL. (7)Females whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 800 mL. (8)Individuals currently participating in, recently completing, or planning to participate in another clinical study. (9)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. (10)Individuals undergoing medical treatment at the time of the eligibility assessment. (11)Individuals regularly taking medications that may affect study outcomes. (12)Regular users of FOSHU, FFC, supplements, or other health foods that may affect study outcomes. (13)Individuals smoking >=21 cigarettes/day. (14)Individuals with excessive alcohol consumption. (15)Individuals with irregular lifestyles, including shift workers. (16)Individuals unable to consume the study foods as instructed. (17)Individuals engaging in regular vigorous exercise. (18)Individuals expecting major lifestyle changes during the study. (19)Individuals who are unwilling or unable to engage in regular exercise throughout the study period. (20)Individuals judged ineligible by the Principal Investigator or Sub-Investigator. Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 28 Day Date of IRB - 2026 Year 11 Month 11 Day Anticipated trial start date - 2026 Year 11 Month 14 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072793

Disclaimer: Curated by HT Syndication.