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Green Coffee Extract and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02764957
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Study Description
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Brief Summary:
Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: green coffee extract Dietary Supplement: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : April 21, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: intervention
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
Placebo Comparator: control
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
 Dietary Supplement: placebo


Outcome Measures
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Primary Outcome Measures :
  1. fasting blood glucose [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. HOMA-IR [ Time Frame: 8 weeks ]
  2. blood pressure [ Time Frame: 8 weeks ]
  3. insulin [ Time Frame: 8 weeks ]
  4. hemoglubin A1c [ Time Frame: 8 weeks ]
  5. triglyceride [ Time Frame: 8 weeks ]

Eligibility Criteria
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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:

  • Waist circumference>102 cm in men and >88 cm in women
  • Fasting blood glucose>100 mg/dL (5.6 mmol /L)
  • Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
  • Triglycerides> 150 mg/dL (1.7 mmol/L)

Exclusion Criteria:

  • Insulin administration
  • Pregnancy and breastfeeding
  • regular consumption of coffee and green tea
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764957


Locations
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Iran, Islamic Republic of
NNFTRI clinic
Tehran, Iran, Islamic Republic of, 19435
Sponsors and Collaborators
National Nutrition and Food Technology Institute
More Information
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Responsible Party: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02764957     History of Changes
Other Study ID Numbers: NationalNFTI
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases