Green Coffee Extract and Metabolic Syndrome

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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