Green Coffee Effect on Metabolic Syndrome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688917
• Other study ID #: FPTU-11-2020
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Obesity
• Supportive Care
• Syndrome

Intervention

Dietary Supplement:
• Green coffee been extract
supportive treatment

Other:
• Placebo
Placebo capsule

Locations

Country	Name	City	State
Egypt	Naglaa Khedr	Tanta	Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Damanhour University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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 Ova — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adiponectin (µg/mL)	Serum Level	six months
Primary	TNF-a (pg/mL)	Serum Level	six months
Primary	Resistin (ng/mL)	Serum Level	six months
Primary	Homocysteine (µmol/L)	Serum Level	six months
Primary	Hs-CRP (mg/L)	Serum Level	Six months
Secondary	BMI (kg/m2)	Weight / hight squared.	six months
Secondary	LDL-C (mg/dL)	calculated according to Friedewald formula.	six Months