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Completed

NCT Number: NCT02764957

Green Coffee Extract and Metabolic Syndrome

Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NNFTRI clinic

Tehran, 19435, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Waist circumference>102 cm in men and >88 cm in women
  • Fasting blood glucose>100 mg/dL (5.6 mmol /L)
  • Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
  • Triglycerides> 150 mg/dL (1.7 mmol/L)

Exclusion criteria

  • Insulin administration
  • Pregnancy and breastfeeding
  • regular consumption of coffee and green tea

Treatment and study plan

green coffee extract

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. fasting blood glucose

    Time frame: 8 weeks

Secondary outcomes

  1. HOMA-IR

    Time frame: 8 weeks

  2. blood pressure

    Time frame: 8 weeks

  3. insulin

    Time frame: 8 weeks

  4. hemoglubin A1c

    Time frame: 8 weeks

  5. triglyceride

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 6, 2016
Registry last updated
Aug 28, 2017

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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