Back to resultsGreen Coffee Effect on Metabolic Syndrome
Primary Purpose
Supportive Care, Metabolic Syndrome, Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Green coffee been extract
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Supportive Care
Eligibility Criteria
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
Sites / Locations
- Naglaa Khedr
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
green been extract treated group
Placebo group
Arm Description
Participants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule
Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.
Outcomes
Primary Outcome Measures
Adiponectin (µg/mL)
Serum Level
TNF-α (pg/mL)
Serum Level
Resistin (ng/mL)
Serum Level
Homocysteine (µmol/L)
Serum Level
Hs-CRP (mg/L)
Serum Level
Secondary Outcome Measures
BMI (kg/m2)
Weight / hight squared.
LDL-C (mg/dL)
calculated according to Friedewald formula.
Full Information
NCT ID
NCT05688917
First Posted
January 24, 2021
Last Updated
May 24, 2023
Sponsor
Tanta University
Collaborators
Damanhour University
1. Study Identification
Unique Protocol Identification Number
NCT05688917
Brief Title
Green Coffee Effect on Metabolic Syndrome
Official Title
Effect of Green Coffee Supplementation on Inflammatory Biomarkers in Obese Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Damanhour University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supportive Care, Metabolic Syndrome, Obesity, Hypertension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
160 obese patients supplemented with GCBE capsules (800 mg) daily for six months
Masking
ParticipantInvestigator
Masking Description
double-blind randomised controlled study
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
green been extract treated group
Arm Type
Experimental
Arm Description
Participants included in the study were maintained on a balanced diet and supplemented with Green Coffee Bean (Coffea Arabica) extract capsules (800 mg/capsule
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants included in the study were maintained on a balanced diet and supplemented with placebo capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green coffee been extract
Intervention Description
supportive treatment
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Primary Outcome Measure Information:
Title
Adiponectin (µg/mL)
Description
Serum Level
Time Frame
six months
Title
TNF-α (pg/mL)
Description
Serum Level
Time Frame
six months
Title
Resistin (ng/mL)
Description
Serum Level
Time Frame
six months
Title
Homocysteine (µmol/L)
Description
Serum Level
Time Frame
six months
Title
Hs-CRP (mg/L)
Description
Serum Level
Time Frame
Six months
Secondary Outcome Measure Information:
Title
BMI (kg/m2)
Description
Weight / hight squared.
Time Frame
six months
Title
LDL-C (mg/dL)
Description
calculated according to Friedewald formula.
Time Frame
six Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab H Werida, Ass. Prof.
Organizational Affiliation
Damanhour University
Official's Role
Study Chair
Facility Information:
Facility Name
Naglaa Khedr
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
35127
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Not applicable. the data will published in specialized journal
IPD Sharing Time Frame
12 months
IPD Sharing Access Criteria
data after analysis
Citations:
PubMed Identifier
36231426
Citation
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.
Results Reference
background
PubMed Identifier
29307310
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 clinical trial. Br J Nutr. 2018 Feb;119(3):250-258. doi: 10.1017/S0007114517003439. Epub 2018 Jan 8.
Results Reference
result
PubMed Identifier
36381474
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 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.
Results Reference
result
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Green Coffee Effect on Metabolic Syndrome
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