Dose-ranging study to evaluate efficacy of amino acid mixture on body fat reduction in overweight adults
Phase 2
- Conditions
- Overweight
- Registration Number
- JPRN-UMIN000019870
- Lead Sponsor
- Food Science Research Laboratories, Meiji Co., Ltd.
- Brief Summary
Compared with placebo, a medium or low dose of the amino acid mixture may facilitate abdominal fat reduction among overweight adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1. Current or past history of severe diseases 2. Heavy alcohol drinkers 3. Heavy smokers 4. Individuals who have extremely irregular dietary habits 5. Individuals who are pregnant or nursing or desire pregnancy during the study 6. Constant use or past history during the last 6 months of oral medication or supplements potentially affecting the study outcomes 7. Phenylketonuria, and hyperphenylalaninemia 8. Participation in other clinical studies during the last 6 months 9. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-month changes in abdominal fat areas
- Secondary Outcome Measures
Name Time Method 3-month changes in body weight, percent body fat, waist circumference, skinfold thickness, dietary intake, physical activity, triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol and tryglyceride including 4 major classes and 20 subclasses, number of lipoprotein particle, fasting plasma glucose, hemoglobin A1c, and insulin