NCT01778257
Completed
Phase 2
Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
ConditionsObesity
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 30
- Primary Endpoint
- Changes in body and abdominal fat
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.
Detailed Description
The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial. Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.
Investigators
Min-Gul Kim, MD
Clinical Assistant Professor
Chonbuk National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Volunteers aged 19 to 65 years
- •25 kg/m2 ≤ BMI ≥35 kg/m2
- •Ability to give informed consent
Exclusion Criteria
- •Significant variation in weight (more 10%) in the past 3 month
- •Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
- •History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
- •Allergic or hypersensitive to any of the ingredients in the test products
- •Pregnancy or breast feeding
- •Used antipsychosis drugs therapy within past 2 months
- •History of alcohol or substance abuse (21 units/week over)
- •Participation in any other clinical trials within past 3 months
Outcomes
Primary Outcomes
Changes in body and abdominal fat
Time Frame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks
Secondary Outcomes
- Changes in anthropometric parameters(weight, BMI, waist and hip circumference)(baseline, 6 weeks and 12 weeks)
- Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)(baseline, 6 weeks and 12 weeks)
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