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

N

National Nutrition and Food Technology Institute

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: green coffee extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03265184
NationalNFTI1355

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups, including a placebo group

intervention group
Experimental group
Description:
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
Treatment:
Dietary Supplement: green coffee extract
placebo group
Placebo Comparator group
Description:
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Treatment:
Dietary Supplement: green coffee extract

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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