Green Coffee Extract and Metabolic Syndrome

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

Tracking Information

• First Submitted Date: May 1, 2016
• First Posted Date: May 6, 2016
• Last Update Posted Date: August 28, 2017
• Actual Study Start Date: December 1, 2016
• Actual Primary Completion Date: March 21, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 4, 2017): fasting blood glucose [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures (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 (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 (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: Green Coffee Extract and Metabolic Syndrome
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Metabolic Syndrome

Intervention

• Dietary Supplement: green coffee extract
• Dietary Supplement: placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 4, 2017): 43
• Original Estimated Enrollment (submitted: May 4, 2016): 60
• Actual Study Completion Date: April 21, 2017
• Actual Primary Completion Date: March 21, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT02764957
• Other Study ID Numbers: NationalNFTI
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
• Study Sponsor: National Nutrition and Food Technology Institute
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: National Nutrition and Food Technology Institute
• Verification Date: August 2017