A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000046535
- Lead Sponsor
- ew drug research center, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 81
Not provided
1) Subjects who fall under the diagnostic criteria of metabolic syndrome 2) Subjects who are under treatment of liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, metabolic disease, neurological disease, consciousness disease, diabetes disease, other disorders 3) Subjects who are have a history of cardiovascular disease 4) Subjects who do not intakecarbohydrates (rice, bread, noodles) for all three meals a day 5) Subjects who use oral medication or supplements which may affect this study 6) Subjects who are sensitive to medical products, and other foods 7) Subjects who have experienced sickness due to blood collection 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) Subjects who participated in other clinical studies in the past 1 months 10) Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=) 11) Subjects who with irregular eating habits. (Night shift worker) 12) Subjects who wish to become pregnant during the study periods( including the possibility of pregnant) or who are lactation. 13) Subjects who can not agree with preliminary explanation 14) Subjects who gained or lost 5% or more of weight within 6 month from the study 15) Subjects who are ineligible due to physician's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visceral fat area
- Secondary Outcome Measures
Name Time Method Subcutaneous fat area, Total fat area, Body weight, BMI, Body fat percentage, Waist circumference, Intestinal flora, Fecal organic acid, Breath gas (O2, CO2)