Green Coffee Modulates Metabolic Syndrome

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05688917
• Collaborator: Damanhour University (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Supportive Care; Metabolic Syndrome; Obesity; Hypertension	Dietary Supplement: Green coffee been extract; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 160 obese patients supplemented with GCBE capsules (800 mg) daily for six months160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
• Masking: Double (Participant, Investigator)
• Masking Description: double-blind randomised controlled study
• Primary Purpose: Supportive Care
• Official Title: Green Coffee Extract Modulates Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome
• Actual Study Start Date: Nov 3, 2020
• Actual Primary Completion Date: Sep 1, 2022
• Actual Study Completion Date: Oct 30, 2022

Arms and Interventions

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 care
Placebo Comparator: Placebo group Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.	Other: Placebo; Placebo casule

Outcome Measures

Primary Outcome Measures

1. Adiponectin (µg/mL) [six months]

   Serum Level

2. TNF-α (pg/mL) [six months]

   Serum Level

3. Resistin (ng/mL) [six months]

   Serum Level

4. Homocysteine (µmol/L) [six months]

   Serum Level

5. Hs-CRP (mg/L) [Six months]

   Serum Level

Secondary Outcome Measures

1. BMI (kg/m2) [six months]

   Weight / hight squared.

2. LDL-C (mg/dL) [six Months]

   calculated according to Friedewald formula.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naglaa Khedr	Tanta	Gharbia	Egypt	35127

Sponsors and Collaborators

• Tanta University
• Damanhour University

Investigators

• Study Chair: Rehab H Werida, Ass. Prof., Damanhour University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Naglaa Khedr, Professor of Biochemistry, Tanta University
• ClinicalTrials.gov Identifier: NCT05688917
• Other Study ID Numbers: FPTU-11-2020
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jan 31, 2023