Green Coffee Extract and Metabolic Syndrome

Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: green coffee extract

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19435
    • NNFTRI clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fasting blood glucose	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
HOMA-IR	8 weeks
insulin	8 weeks
blood pressure	8 weeks
hemoglubin A1c	8 weeks
triglyceride	8 weeks

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 21, 2017
• Study Completion (Actual): April 21, 2017

Study Registration Dates

• First Submitted: May 1, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: NationalNFTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED