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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Mate extract; Dietary Supplement: Placebo

• Registration Number: NCT01778257
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Study First Submitted: 2012-12-07
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-25
• Last Update Submitted: 2013-01-25
• Study First Posted: 2013-01-29
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mate extracts group	Mate extract	Mate extract(3150 mg/day)for 12 weeks
Placebo group	Placebo	Placebo (3150 mg/day) for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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