Verification study on the effect of food material intake on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-

UMIN ID: UMIN000044727

Registered date:02/07/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2021/08/17
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test food for 12 weeks
Intake of placebo food for 12 weeks

Outcome(s)

• Primary Outcome: Visceral fat area
• Secondary Outcome: Body weight,BMI,Waist circumference,hip circumference, W/H ratio,Subcutaneous fat area,total fat area,total cholesterol,LDL- cholesterol,HDL- cholesterol,triglyceride,glucose,HbA1c

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)Subjects who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2)Subjects who dyslipidemia, high blood pressure, or diabetes 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4)Subjects who regularly use health foods and supplements affecting the study 5)Possible pregnancy, pregnancy and lactation 6)Heavy drinkers 7)Subjects who feel bad mood by blood collect 8)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 9)Those who have been diagnosed with chronic constipation 10)Shift worker 11)Subjects who plan business trip or trip for 10 days or more a month 12)Subjects who have allergy related to the test foods 13)Subjects already participating in other clinical trials 14)Subjects who are ineligible due to physician's judgment

Related Information

• Primary Sponsor: Maruzen Pharmaceuticals Co., Ltd.
• Source(s) of Monetary Support: Maruzen Pharmaceuticals Co., Ltd.