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

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

Drug Information available for: Ilex paraguariensis

U.S. FDA Resources

Arms and Interventions

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

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 ]

Secondary Outcome Measures :

Changes in anthropometric parameters(weight, BMI, waist and hip circumference) [ Time Frame: 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim SY, Oh MR, Kim MG, Chae HJ, Chae SW. Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2015 Sep 25;15:338. doi: 10.1186/s12906-015-0859-1.

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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

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