Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000028706
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1.Subjects who takes oral medication affecting obesity, hyperlipidemia and lipid metabolism 2.Subjects who suffer a severe illness in liver, cardiovascular, respiratory, endocrine, metabolism and allergy 3.Subjects who are not able to stop to take in food or supplement affecting obesity, hyperlipidemia and lipid metabolism 4.Subjects who have under treatment or a history of drug addiction and/or alcoholism 5.Subjects who have a metal component in the abdomen 6.Subjects who have a cardiac pacemaker 7.Subjects who have food allergy 8.Subjects who were diagnosed as familial hyperlipidemia 9.Pregnant and lactating female, or who wish to get pregnant during the study period 10. Subjects who is already participating or participated within 1 month in other clinical trials, subjects planning to participate during this examination period 11.Subjects who are ineligible due to physician's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal visceral fat area, abdominal subcutaneous fat area, and abdominal total fat area, at 12weeks after intake
- Secondary Outcome Measures
Name Time Method Body weight(BMI), abdominal circumherence, fasting blood sugar level and serum lipids(total cholesterol, LDL-cholesterol, Triglycerides), at 6 and 12weeks after intake Measurement of intestinal flora and adiponectin(polymer), at 12weeks Defecation frequency and stool output