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

• ClinicalTrials.gov Identifier: NCT01778257
• Recruitment Status: Completed
• First Posted: January 29, 2013
• Last Update Posted: January 29, 2013
• Sponsor: Chonbuk National University Hospital
• 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

• 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

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 :

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

• 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

Sponsors and Collaborators

Chonbuk National University Hospital

GS Engineering & Construction

Investigators

• 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.

• 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
• First Posted: January 29, 2013
• 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:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms