A study evaluating the body fat reduction effects of the test food

UMIN ID: UMIN000055996

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/11/17
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Daily intake of the test food for 12 weeks
Daily intake of placebo (control food) for 12 weeks

Outcome(s)

• Primary Outcome: Body fat (total fat area)
• Secondary Outcome: 1)Visceral fat area 2)Subcutaneous fat area 3)Body weight 4)BMI 5)Body fat weight 6)Body fat percentage 7)Fat free mass 8)Waist circumference 9)Hip circumference 10)Waist/hip ratio 11)Segmental muscle mass (limbs and trunk) 12)Triglycerides 13)Total cholesterol 14)HDL-cholesterol 15)LDL-cholesterol 16)Fasting blood glucose 17)Insulin 18)HbA1c 19)HOMA-IR 20)Comprehensive analysis of gut bacteria composition

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1)Those who are on treatment or have a history of malignant tumors, heart failure, or myocardial infarction. 2)Those with a pacemaker or implantable cardioverter defibrillator. 3)Those who are currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases. 4)Those who regularly use medicines, quasi-drugs, supplements, and diet foods that affect body fat. 5)Those who cannot refrain from consuming health foods that affect body fat. 6)Those who cannot refrain from consuming foods/ drinks containing lactic acid bacteria other than the test foods (yogurt, lactic acid drinks such as Yakult, etc.). 7)Those who regularly drink an amount of alcohol exceeding the recommended amount. 8)Those who smoke an average of more than 20 cigarettes per day. 9)Those with extremely irregular lifestyles (those who work night shifts or shift rotations). 10)Those who have large changes in their diet and exercise habits and are unable to maintain their daily lifestyle. 11)Those who underwent a barium examination 2 weeks prior to the CT scan. 12)Those with metal or other materials embedded in the area to be CT scanned. 13)Those whose weight change in the past year is outside the range of 1 to 2 kg. 14)Those who regularly exercise. 15)Those who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test. 16)Those who have a dairy allergy or who have hypersensitive reactions to the test foods. 17)Those who are pregnant, breastfeeding or planning to become pregnant during the study period. 18)Those who participated in other clinical trials within a month prior to the date of consent, or plan to participate in other clinical trials during the study period. 19)Those who are judged as ineligible for the study by the investigator.

Related Information

• Primary Sponsor: APO PLUS STATION CO., LTD.
• Source(s) of Monetary Support: MEGMILK SNOW BRAND Co., Ltd.