Green Coffee Effect on Metabolic Syndrome

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Metabolic Syndrome; Supportive Care
• Intervention / Treatment: Other: Placebo; Dietary supplement: Green coffee been extract

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 35127
      • Naglaa Khedr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: green been extract treated group; 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; supportive treatment
Placebo Comparator: Placebo group; Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.	Other: Placebo; Placebo capsule

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric upset	Ulcer and hyper-acidity- ultrasound investigation	six months
GIT symptoms	Diarrhea or constipation	six months

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Damanhour University
• Investigators: Study Chair: Rehab H Werida, Ass. Prof., Damanhour University

Publications and helpful links

General Publications

• Lange E, Keszycka PK, Palkowska-Gozdzik E, Billing-Marczak K. Comparison of Glycemic Response to Carbohydrate Meals without or with a Plant-Based Formula of Kidney Bean Extract, White Mulberry Leaf Extract, and Green Coffee Extract in Individuals with Abdominal Obesity. Int J Environ Res Public Health. 2022 Sep 25;19(19):12117. doi: 10.3390/ijerph191912117.
• Roshan H, Nikpayam O, Sedaghat M, Sohrab G. Effects of green coffee extract supplementation on anthropometric indices, glycaemic control, blood pressure, lipid profile, insulin resistance and appetite in patients with the metabolic syndrome: a randomised clinical trial. Br J Nutr. 2018 Feb;119(3):250-258. doi: 10.1017/S0007114517003439. Epub 2018 Jan 8.
• Meshkani M, Saedisomeolia A, Yekaninejad M, Mousavi SA, Ildarabadi A, Vahid-Dastjerdi M. The Effect of Green Coffee Supplementation on Lipid Profile, Glycemic Indices, Inflammatory Biomarkers and Anthropometric Indices in Iranian Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. Clin Nutr Res. 2022 Oct 28;11(4):241-254. doi: 10.7762/cnr.2022.11.4.241. eCollection 2022 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: FPTU-11-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Not applicable. the data will published in specialized journal
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: data after analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No