Green Coffee Extract and Metabolic Syndrome

NCT ID: NCT02764957

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-04-21

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

green coffee extract

Intervention Type DIETARY_SUPPLEMENT

control

placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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green coffee extract

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Dr Azita Hekmatdoost

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NNFTRI clinic

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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NationalNFTI

Identifier Type: -

Identifier Source: org_study_id

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