A study to evaluate the anti-obesity effects of continuous intake with food containing multiple ingredients
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000048605
- Lead Sponsor
- FUKUOKA KINEN PET KENSHIN CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Subjects with a history of hepatic, renal, cardiac or organ disorders, diabetes or other serious diseases. 2) Subjects with a surgical history of digestive system (except appendicectomy). 3) Subjects currently under treatment with chronic diseases. 4) Subjects with food allergies to the food ingredients used in the study. 5) Subjects who wish to become pregnant during the study period or who are lactating or pregnant or may be pregnant. 6) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day). 7) Subjects who take the supplement containing lactoferrin, mulberry extract, salacia extract, pueraria flower extract, irvingia gabonensis extract, DHA/EPA or rosehip extract, or general food such as protein diet, for 3 days or more per week and have continued to take it for 6 months or more. And the subjects who cannot stop taking the supplement or the general food during study periods (from application to last visit) 8) Subjects taking the medicines (for example the Bislat Gold EX or the Naishitol Za), the Chinese medicine (for example the Bofutsushosan or the Daisaikoto ) or the supplements claiming for the reduction of the body fat on diet. 9) Subjects who are participating in clinical trials or consumer monitoring other than this study or who are planning to participate during this study period. 10) Subjects who have donated 200 ml or more of blood after 1 month before the primary screening or plan to donate them before the end of the study separately from this study. 11) Subjects who frequently skip breakfast. 12) Subjects who work during 22:00 to 6:00 (shift worker, night- shift worker, etc including part-timer). 13) Subject who need to avoid consuming foods whose origin is not clearly indicated due to religious or other reasons. 14) Subjects judged as unsuitable for this study by the investigator with other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The area of abdominal total, visceral and subcutaneous fat
- Secondary Outcome Measures
Name Time Method Triglyceride, Blood glucose, Body weight, BMI, Blood pressure, Body fat percentage, Waist circumference