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

NCT01778257 | Completed Phase 2 DMC

• 1 other identifier: CUH_2011_GS_MATE
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity

Keywords

Mate extracts; Obesity; abdominal fat

Outcome Measures

Primary Outcomes (1)

• Changes in body and abdominal fat

  body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks

Secondary Outcomes (2)

• Changes in anthropometric parameters(weight, BMI, waist and hip circumference)

  baseline, 6 weeks and 12 weeks

• Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)

  baseline, 6 weeks and 12 weeks

Study Arms (2)

Mate extracts group

EXPERIMENTAL

Mate extract(3150 mg/day)for 12 weeks

Dietary Supplement: Mate extract

Placebo group

PLACEBO COMPARATOR

Placebo (3150 mg/day) for 12 weeks

Dietary Supplement: Placebo

Interventions

Mate extract DIETARY_SUPPLEMENT

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

Also known as: Extracts of Ilex paraguariensis A. St.-Hil.

Mate extracts group

Placebo DIETARY_SUPPLEMENT

Amount and calorie of placebo are same with Mate extracts.

Placebo group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers aged 19 to 65 years
• kg/m2 ≤ BMI ≥35 kg/m2
• Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead
• GS Engineering & Construction: collaborator

Related Publications (1)

• 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.

  PMID: 26408319 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Min-Gul Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: January 29, 2013
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2013-01