Back to resultsGreen Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
green coffee extract
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
Exclusion Criteria:
- insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
placebo group
Arm Description
400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Outcomes
Primary Outcome Measures
intercellular adhesion molecule-1 (ICAM-1)
interleukin-6 (IL-6)
high sensitivity C-reactive protein (hs-CRP)
malondialdehyde (MDA)
Secondary Outcome Measures
Full Information
NCT ID
NCT03265184
First Posted
August 25, 2017
Last Updated
August 25, 2017
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT03265184
Brief Title
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
Official Title
Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Intervention Type
Dietary Supplement
Intervention Name(s)
green coffee extract
Intervention Description
Patients in treatment group take 400 mg GCE supplements twice a day for tow month
Primary Outcome Measure Information:
Title
intercellular adhesion molecule-1 (ICAM-1)
Time Frame
8 weeks
Title
interleukin-6 (IL-6)
Time Frame
8 weeks
Title
high sensitivity C-reactive protein (hs-CRP)
Time Frame
8 weeks
Title
malondialdehyde (MDA)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
body mass index of over 25, waist circumference >102 cm in men or >88 cm in women,Fasting blood glucose >100 mg/dL, Triglycerides (TG) > 150 mg/dL, High density lipoprotein cholesterol (HDL-C) <50 in women or <40 in men, Systolic blood pressure (SBP) >130 mmHg and diastolic blood pressure (DBP) >85mmHg
Exclusion Criteria:
insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
12. IPD Sharing Statement
Learn more about this trial
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
We'll reach out to this number within 24 hrs