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Completed

NCT Number: NCT02116517

Effects of Green Tea Extract on Obese Women With High Level of LDL

Green tea is one of the most popular beverages in the world. It is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese with high LDL level.

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Key information

Conditions

Obese Body Weight Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Taipei City Hospital

Taipei, 886, Taiwan

About this study

Randomized, double-blind, crossover placebo-controlled clinical trial

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 18 and 65 years
  • body mass index (BMI) >= 27 kg/m2
  • fasting low-density-lipoprotein cholesterol (LDL) >= 130mg/dl and (4) willing to participate in this trial.

Exclusion criteria

  • serum alanine transaminase > 80 U/L
  • serum creatinine > 1.8 mg/dl
  • breast feeding or pregnancy
  • heart failure, acute myocardial infarction, stroke, heavy injury
  • any other conditions not suitable for trial as evaluated by the physician. -

Treatment and study plan

Green Tea Extract

Dietary Supplement

500 mg three times per day

Other names: EGCG

Placebo

Dietary Supplement

cellulose 500mg three times a day for 6 weeks

Other names: cellulose

Primary outcomes

  1. percentage of reduction of LDL-C

    Time frame: 6 weeks of treatment

    level of LDL-C before intervention minus level of LDL-C after intervention equal to reduction of LDL-C, percentage of reduction of LDL-C equal to the level of reduction of LDL-C divided by level of LDL-C before intervention

Secondary outcomes

  1. HDL-C

    Time frame: 6 weeks

    serum level of high density lipoprotein cholesterol

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Taipei City Hospital

Registry information

Official study title

Phase 3 Study; Effects of Green Tea Extract on Obese Women With High Level of Low Density Lipoprotein (LDL): a Randomized, Double-blinded, and Cross-over Placebo-controlled Clinical Trial

Acronym: GTE-LDL

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2014
Registry last updated
Apr 17, 2014

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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