Green Coffee Effect on Metabolic Syndrome

Not Applicable

Completed

• Conditions: Supportive Care; Metabolic Syndrome; Obesity; Hypertension
• Interventions: Dietary Supplement: Green coffee been extract; Other: Placebo

• Registration Number: NCT05688917
• Lead Sponsor: Tanta University

Brief Summary

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

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

Study Timeline

• Study Start: 2020-09-03
• Study First Submitted: 2021-01-24
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
green been extract treated group	Green coffee been extract	Participants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule
Placebo group	Placebo	Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.

Primary Outcome Measures

Name	Time	Method
Hs-CRP (mg/L)	Six months	Serum Level
TNF-α (pg/mL)	six months	Serum Level
Adiponectin (µg/mL)	six months	Serum Level
Resistin (ng/mL)	six months	Serum Level
Homocysteine (µmol/L)	six months	Serum Level

Secondary Outcome Measures

Name	Time	Method
LDL-C (mg/dL)	six Months	calculated according to Friedewald formula.
BMI (kg/m2)	six months	Weight / hight squared.

Trial Locations

Locations (1)

Naglaa Khedr; 🇪🇬 Tanta, Gharbia, Egypt