NCT02764957

Green Coffee Extract and Metabolic Syndrome

Completed Phase 2, PHASE3 Last updated 28 August 2017

What this trial tests

Phase 2, PHASE3 trial testing green coffee extract in Metabolic Syndrome in 43 participants. Completed in 21 April 2017.

Timeline

1 December 2016

Primary endpoint
21 March 2017

21 April 2017

Quick facts

Lead sponsor	National Nutrition and Food Technology Institute
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	43
Start date	1 December 2016
Primary completion	21 March 2017
Estimated completion	21 April 2017
Sites	1 location across Iran

Drugs / interventions tested

• green coffee extract
• placebo

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

National Nutrition and Food Technology Institute

Who can join

Adults 18 to 70, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Could Natural Products Help in the Control of Obesity? Current Insights and Future Perspectives.
   Park J, Nurkolis F, Won H, Yang J, et al · · 2023 · cited 6× · PMID 37764380 · DOI 10.3390/molecules28186604