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OpenTrials
Completed

NCT Number: NCT01778257

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

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

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Key information

Conditions

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

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mate extract

Dietary Supplement

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

Other names: Extracts of Ilex paraguariensis A. St.-Hil.

Placebo

Dietary Supplement

Amount and calorie of placebo are same with Mate extracts.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • GS Engineering & Construction

Registry information

Official study title

Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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