Green Coffee Extract and Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: placebo; Dietary Supplement: green coffee extract

• Registration Number: NCT02764957
• Lead Sponsor: National Nutrition and Food Technology Institute

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 available

Study Timeline

• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2016-12-01
• Primary Completion: 2017-03-21
• Study Completion: 2017-04-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	placebo	placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
intervention	green coffee extract	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

Primary Outcome Measures

Name	Time	Method
fasting blood glucose	8 weeks

Secondary Outcome Measures

Name	Time	Method
HOMA-IR	8 weeks
blood pressure	8 weeks
insulin	8 weeks
hemoglubin A1c	8 weeks
triglyceride	8 weeks

Trial Locations

Locations (1)

NNFTRI clinic; 🇮🇷 Tehran, Iran, Islamic Republic of