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

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ClinicalTrials.gov Identifier: NCT01778257
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Collaborator:
GS Engineering & Construction
Information provided by (Responsible Party):
Min-Gul Kim, MD, Chonbuk National University Hospital

Study Description
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Brief Summary:
Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Mate extract Dietary Supplement: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in body and abdominal fat [ Time Frame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778257


Sponsors and Collaborators
Chonbuk National University Hospital
GS Engineering & Construction
Investigators
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Principal Investigator: Min-Gul Kim, MD Chonbuk National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Min-Gul Kim, MD, Clinical Assistant Professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01778257    
Other Study ID Numbers: CUH_2011_GS_MATE
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Keywords provided by Min-Gul Kim, MD, Chonbuk National University Hospital:
Mate extracts
Obesity
abdominal fat
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight