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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014