Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects

Study Overview
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Brief Summary
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Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.

Detailed Description
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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.

Official Title
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Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Mate extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mate extracts group<br>Mate extract(3150 mg/day)for 12 weeks | Dietary Supplement: Mate extract<br>* Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.<br>* Other names: Extracts of Ilex paraguariensis A. St.-Hil.;|
| Placebo Comparator: Placebo group<br>Placebo (3150 mg/day) for 12 weeks | Dietary Supplement: Placebo<br>* Amount and calorie of placebo are same with Mate extracts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body and abdominal fat |  | body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mate extracts, Obesity, abdominal fat