- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778257
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
|
Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.
Other Names:
|
Placebo Comparator: Placebo group
Placebo (3150 mg/day) for 12 weeks
|
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.
Collaborators
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.
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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