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Completed

NCT Number: NCT05688917

Green Coffee Effect on Metabolic Syndrome

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

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Key information

Conditions

Supportive Care Body Weight Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naglaa Khedr

Tanta, Gharbia Governorate, 35127, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Green coffee been extract

Dietary Supplement

supportive treatment

Placebo

Other

Placebo capsule

Primary outcomes

  1. Adiponectin (µg/mL)

    Time frame: six months

    Serum Level

  2. TNF-α (pg/mL)

    Time frame: six months

    Serum Level

  3. Resistin (ng/mL)

    Time frame: six months

    Serum Level

  4. Homocysteine (µmol/L)

    Time frame: six months

    Serum Level

  5. Hs-CRP (mg/L)

    Time frame: Six months

    Serum Level

Secondary outcomes

  1. BMI (kg/m2)

    Time frame: six months

    Weight / hight squared.

  2. LDL-C (mg/dL)

    Time frame: six Months

    calculated according to Friedewald formula.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Damanhour University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
May 26, 2023

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.

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