Metabolic Syndrome Clinical Trial
Official title:
Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
| Verified date | August 2017 |
| Source | National Nutrition and Food Technology Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | July 18, 2017 |
| Est. primary completion date | June 12, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Nutrition and Food Technology Institute |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | intercellular adhesion molecule-1 (ICAM-1) | 8 weeks | ||
| Primary | interleukin-6 (IL-6) | 8 weeks | ||
| Primary | high sensitivity C-reactive protein (hs-CRP) | 8 weeks | ||
| Primary | malondialdehyde (MDA) | 8 weeks |
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