Clinical Trial: Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat-Randomized, placebo-controlled, double-blind, parallel group study- (Japan)

Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060853) titled 'Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat-Randomized, placebo-controlled, double-blind, parallel group study-' on March 6.

Study Type: Interventional

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

Primary Sponsor: Institute - Maruzen Pharmaceuticals Co., Ltd.

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

Objective: Narrative objectives1 - To investigate for effects of abdominal fat reduction when supplementing with Food Ingredient Mixture (FD-2553) for 12 weeks in adult males and females with BMI of 23.0-29.9 kg/m^2 Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of active food for 12 weeks Interventions/Control_2 - Intake of placebo food for 12 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1)Males and females aged of 20-64 years 2)Participants whose BMI 23.0-29.9 kg/m^2 3)Participants who can visit on schedule days 4)Participants who recognize the object and contents of the study and submit the written informed consent Key exclusion criteria - 1)Participants who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2)Participants who have been diagnosed with, or have a past medical history of dyslipidemia, high blood pressure, or diabetes 3)Participants with a condition that may affect body weight or body fat 4)Participants who joined a weight loss program or similar initiative within three months prior to the start of the screening examination, or participants who experienced significant weight change (a change of 5 kg or more) 5)Participants who received medication treatment or surgery due to serious illness or injury within 1 month prior to the start of this study 6)Participants who regularly use health foods and supplements affecting the study 7)Participants who may have difficulties during CT scanning (e.g. claustrophobia, metal in the vicinity of imaging, implanted medical devices in the body) 8)Possible pregnancy, pregnancy and lactation 9)Heavy drinker (40g alcohol/day or more) 10)Excessive smokers (21 cigarettes/day or more) 11)Participants who feel bad mood by blood collect 12)Participants who donated 200 mL or more of blood within 1 month prior to the start of screening tests or participants who plan to do so during the study period 13)Participants who have been diagnosed with chronic constipation 14)Late-night shift worker 15)Participants who plan business trip or other travel averaging more than 10 days per month 16)Participants who have allergies related to the test foods 17)Participants already participating in other clinical trials, or who plan to participate in other clinical trials during the study period 18)Participants who are ineligible due to physician's judgment Target Size - 104

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 20 Day Date of IRB - 2026 Year 03 Month 02 Day Anticipated trial start date - 2026 Year 04 Month 24 Day Last follow-up date - 2026 Year 08 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069623

Disclaimer: Curated by HT Syndication.