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NCT02764957 Clinical Trial

Green Coffee Extract and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02764957
Other study ID # NationalNFTI
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 1, 2016
Last updated August 25, 2017
Start date December 1, 2016
Est. completion date April 21, 2017

Study information
Verified date August 2017
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date April 21, 2017
Est. primary completion date March 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• green coffee extract

• placebo

Locations
Country Name City State
Iran, Islamic Republic of NNFTRI clinic Tehran

Sponsors (1)
Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary fasting blood glucose 8 weeks
Secondary HOMA-IR 8 weeks
Secondary blood pressure 8 weeks
Secondary insulin 8 weeks
Secondary hemoglubin A1c 8 weeks
Secondary triglyceride 8 weeks
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