Effect of Food Containing Plant Extract on Body Fat Reduction -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000053493
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Not provided
Subjects who 1)use habitually medications. 2)contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). 3)have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator). 4)have been implanted metal in the abdominal area, as detected by computerized tomography. 5)have claustrophobia. 6)have declared allergic reaction to ingredients of test foods. 7)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 8)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia , lipid metabolism, and so on during test periods. 9)can't stop drinking from 2 days before each measurement. 10)are under treatment for or have a history of drug addiction and/or alcoholism. 11)have been diagnosed as familial hyperlipidemia. 12)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. 13)are shift worker, midnight-shift worker, and/or subjects with extremely irregular dietary habits. 14)were judged as unsuitable for the current study by screening tests. 15)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 16)are pregnant or planning to become pregnant or breastfeed. 17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 18)are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal fat area
- Secondary Outcome Measures
Name Time Method Other indexes of body fat and questionnaire