Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets

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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

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg

Exclusion criteria

insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans

Treatment and study plan

green coffee extract

Dietary Supplement

Patients in treatment group take 400 mg GCE supplements twice a day for tow month

Primary outcomes

intercellular adhesion molecule-1 (ICAM-1)

Time frame: 8 weeks
interleukin-6 (IL-6)

Time frame: 8 weeks
high sensitivity C-reactive protein (hs-CRP)

Time frame: 8 weeks
malondialdehyde (MDA)

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 Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 29, 2017
Registry last updated: Aug 29, 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.

Published trials that share one or more normalized conditions with this study.

Completed