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

NCT ID: NCT01778257

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-03-31

Brief Summary

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

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mate extracts group

Mate extract(3150 mg/day)for 12 weeks

Group Type: EXPERIMENTAL

Mate extract

Intervention Type: DIETARY_SUPPLEMENT

Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.

Placebo group

Placebo (3150 mg/day) for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Amount and calorie of placebo are same with Mate extracts.

Interventions

Mate extract

Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Amount and calorie of placebo are same with Mate extracts.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Extracts of Ilex paraguariensis A. St.-Hil.

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GS Engineering & Construction

UNKNOWN

Sponsor Role: collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Min-Gul Kim, MD

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min-Gul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

References

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.

Reference Type: DERIVED

PMID: 26408319 (View on PubMed)

Other Identifiers

CUH_2011_GS_MATE

Identifier Type: -

Identifier Source: org_study_id