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

January 25, 2013 updated by: Min-Gul Kim, MD, Chonbuk National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in anthropometric parameters(weight, BMI, waist and hip circumference)
Time Frame: baseline, 6 weeks and 12 weeks
baseline, 6 weeks and 12 weeks
Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)
Time Frame: baseline, 6 weeks and 12 weeks
baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Collaborators

GS Engineering & Construction

Investigators

  • Principal Investigator: Min-Gul Kim, MD, Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUH_2011_GS_MATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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