Green Coffee Extract and Metabolic Syndrome

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: green coffee extract; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02764957

NationalNFTI

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

intervention

Active Comparator 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

control

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: placebo