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Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

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ClinicalTrials.gov Identifier: NCT03265184
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: green coffee extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
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
Dietary Supplement: green coffee extract
Patients in treatment group take 400 mg GCE supplements twice a day for tow month

Placebo Comparator: placebo group
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Dietary Supplement: green coffee extract
Patients in treatment group take 400 mg GCE supplements twice a day for tow month




Primary Outcome Measures :
  1. intercellular adhesion molecule-1 (ICAM-1) [ Time Frame: 8 weeks ]
  2. interleukin-6 (IL-6) [ Time Frame: 8 weeks ]
  3. high sensitivity C-reactive protein (hs-CRP) [ Time Frame: 8 weeks ]
  4. malondialdehyde (MDA) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Dr Azita Hekmatdoost, National Nutrition and Food Technology Research Institute, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03265184     History of Changes
Other Study ID Numbers: NationalNFTI1355
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

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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

Additional relevant MeSH terms:
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Syndrome
Inflammation
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases