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Green Coffee Effect on Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05688917
Enrollment
160
Registered
2023-01-18
Start date
2020-09-03
Completion date
2022-09-30
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome, Obesity, Supportive Care

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

Interventions

DIETARY_SUPPLEMENTGreen coffee been extract

supportive treatment

OTHERPlacebo

Placebo capsule

Sponsors

Damanhour University
CollaboratorOTHER
Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Masking description

double-blind randomised controlled study

Intervention model description

160 obese patients supplemented with GCBE capsules (800 mg) daily for six months

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TNF-α (pg/mL)six monthsSerum Level
Homocysteine (µmol/L)six monthsSerum Level
Hs-CRP (mg/L)Six monthsSerum Level
Adiponectin (µg/mL)six monthsSerum Level
Resistin (ng/mL)six monthsSerum Level

Secondary

MeasureTime frameDescription
LDL-C (mg/dL)six Monthscalculated according to Friedewald formula.
BMI (kg/m2)six monthsWeight / hight squared.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026