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Green Coffee Extract and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 1, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date August 28, 2017
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
fasting blood glucose [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
fasting blood glucose [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02764957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • HOMA-IR [ Time Frame: 8 weeks ]
  • blood pressure [ Time Frame: 8 weeks ]
  • insulin [ Time Frame: 8 weeks ]
  • hemoglubin A1c [ Time Frame: 8 weeks ]
  • triglyceride [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • malondialdehyde [ Time Frame: 12 weeks ]
  • blood pressure [ Time Frame: 12 weeks ]
  • High sensitive C reactive protein ( hs- CRP) [ Time Frame: 12 weeks ]
  • soluble Intercellular Adhesion Molecules (sICAM) [ Time Frame: 12 weeks ]
  • triglyceride [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Green Coffee Extract and Metabolic Syndrome
Official Title  ICMJE Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: green coffee extract
  • Dietary Supplement: placebo
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2016)
60
Actual Study Completion Date  ICMJE April 21, 2017
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764957
Other Study ID Numbers  ICMJE NationalNFTI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
Study Sponsor  ICMJE National Nutrition and Food Technology Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Nutrition and Food Technology Institute
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP