A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000052822
- Lead Sponsor
- utrione Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
1. Have serious illnesses, or a history of malignant tumor in 6 months or serious illnesses. 2. Have took medicines, quasi-drug, foods or supplements affecting body weight and body fat, or treatment of obesity in one month. 3. Have had bariatric surgery in the past year or are planning to undergo surgery within 6 months after obtaining informed consent. 4. Are obese or overweight due to endocrine diseases, or under treatment or medication for gastrointestinal diseases, or have those history. 5. Have a psychologically serious medical history or illness, or a history of alcohol or other drug abuse. 6. Are judged to be unable to exercise due to skeletal muscle disease. 7. Have lost 3 kg or more of their body weight within the past 3 months. 8. Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable. 9. Receive diet or exercise therapy under medical supervision. 10. Have been taking quasi-drugs, foods, or supplements that affect the outcome of the study. Who can discontinue intake during the study is acceptable. 11. Have allergies to drugs or foods. 12. Shift workers. 13. Plans to extremely change lifestyle during the study. 14. Alcohol drinkers, over an average of 40 g/day. 15. Plans to travel abroad during the study period. 16. Are currently pregnant or breastfeeding, or planning to become pregnant during the study. 17. Have above 200 mL blood donation within one month, or above 400 mL blood donation within 3 months before this study. 18. Had joined other clinical trials from one month before the trial, have currently been joined other clinical trials, or plans to join other clinical trials during the study. 19. Are obsessed with orthopedic metal devices. 20. Are unsuitable for the study, judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -12-week changes in total body fat amount measured by DXA -12-week changes in body fat percentage measured by DXA
- Secondary Outcome Measures
Name Time Method -12-week changes in Lean body mass -12-week changes in body weight -12-week changes in BMI -12-week changes in waist circumference, hip circumference, and ratio waist circumference to hip circumference -12-week changes in fat mass, fat percentage, and lean body mass in each region measured by DXA