Green Coffee Effect on Metabolic Syndrome

Study Overview
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Brief Summary
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The present study aimed to investigate the effect of green coffee bean extract (GCBE) on the inflammatory biomarkers in obese patients with a metabolic syndrome via analyzing some inflammatory biomarkers as resistin, TNF-α, total sialic acid, homocysteine, high sensitivity C-reactive protein (hs-CRP) and anti-inflammatory cytokine, adiponectin

Detailed Description
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160 obese patients supplemented with either GCBE capsules (800 mg) daily or placebo for 6 months and advised to take a balanced diet. Blood samples were collected at baseline and after three months of supplementation

Official Title
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Effect of Green Coffee Supplementation on Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome

Conditions
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Supportive Care, Metabolic Syndrome, Obesity, Hypertension

Intervention / Treatment
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* Dietary Supplement: Green coffee been extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants were enrolled if they were aged 20-60y waist circumference >102 cm in male; 88 cm in female triglycerides ≥150 mg/dL (1.7 mmol/L) HDL-C<40 mg/dL (1.03 mmol/L) in males & <50 mg/dL (1.29 mmol/L) in females systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg. Exclusion Criteria: liver, kidney, coronary artery disease, type I diabetes, autoimmune diseases, cancer, infection, smoking, recent major surgery, routine coffee consumption, pregnancy or breast-feeding, use of anti-inflammatory drugs, corticosteroids, hormone replacement therapy, weight-loss and anti-hypercholesterolemic medications three months or less prior to enrolment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: green been extract treated group<br>Participants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule | Dietary Supplement: Green coffee been extract<br>* supportive treatment<br>|
| Placebo Comparator: Placebo group<br>Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules. | Other: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiponectin (µg/mL) | Serum Level | six months | 
| TNF-α (pg/mL) | Serum Level | six months | 
| Resistin (ng/mL) | Serum Level | six months | 
| Homocysteine (µmol/L) | Serum Level | six months | 
| Hs-CRP (mg/L) | Serum Level | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (kg/m2) | Weight / hight squared. | six months | 
| LDL-C (mg/dL) | calculated according to Friedewald formula. | six Months |