Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

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

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-07-18

Brief Summary

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Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets

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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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intervention group

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 EXPERIMENTAL

green coffee extract

Intervention Type DIETARY_SUPPLEMENT

Patients in treatment group take 400 mg GCE supplements twice a day for tow month

placebo group

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

Group Type PLACEBO_COMPARATOR

green coffee extract

Intervention Type DIETARY_SUPPLEMENT

Patients in treatment group take 400 mg GCE supplements twice a day for tow month

Interventions

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green coffee extract

Patients in treatment group take 400 mg GCE supplements twice a day for tow month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* body mass index of over 25, waist circumference \>102 cm in men or \>88 cm in women,Fasting blood glucose \>100 mg/dL, Triglycerides (TG) \> 150 mg/dL, High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men, Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria

* insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No