Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
1 other identifier
interventional
48
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2017
CompletedFirst Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedAugust 29, 2017
August 1, 2017
5 months
August 25, 2017
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
intercellular adhesion molecule-1 (ICAM-1)
8 weeks
interleukin-6 (IL-6)
8 weeks
high sensitivity C-reactive protein (hs-CRP)
8 weeks
malondialdehyde (MDA)
8 weeks
Study Arms (2)
intervention group
EXPERIMENTAL400 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 group
PLACEBO COMPARATORplacebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Interventions
Patients in treatment group take 400 mg GCE supplements twice a day for tow month
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- National Nutrition and Food Technology Research Institute
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 29, 2017
Study Start
January 1, 2017
Primary Completion
June 12, 2017
Study Completion
July 18, 2017
Last Updated
August 29, 2017
Record last verified: 2017-08