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

This study has been completed.
Sponsor:
Collaborator:
GS Engineering & Construction
Information provided by (Responsible Party):
Min-Gul Kim, MD, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01778257
First received: December 7, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Obesity
Dietary Supplement: Mate extract
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in body and abdominal fat [ Time Frame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in anthropometric parameters(weight, BMI, waist and hip circumference) [ Time Frame: baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
  • Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid) [ Time Frame: baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778257

Sponsors and Collaborators
Chonbuk National University Hospital
GS Engineering & Construction
Investigators
Principal Investigator: Min-Gul Kim, MD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Min-Gul Kim, MD, Clinical Assistant Professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01778257     History of Changes
Other Study ID Numbers: CUH_2011_GS_MATE
Study First Received: December 7, 2012
Last Updated: January 25, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonbuk National University Hospital:
Mate extracts
Obesity
abdominal fat

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014