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Green Coffee Extract and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
green coffee extract
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NNFTRI clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention

control

Arm 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

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

Outcomes

Primary Outcome Measures

fasting blood glucose

Secondary Outcome Measures

HOMA-IR
blood pressure
insulin
hemoglubin A1c
triglyceride

Full Information

First Posted
May 1, 2016
Last Updated
August 25, 2017
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02764957
Brief Title
Green Coffee Extract and Metabolic Syndrome
Official Title
Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
April 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm 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
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
Intervention Type
Dietary Supplement
Intervention Name(s)
green coffee extract
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
fasting blood glucose
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
HOMA-IR
Time Frame
8 weeks
Title
blood pressure
Time Frame
8 weeks
Title
insulin
Time Frame
8 weeks
Title
hemoglubin A1c
Time Frame
8 weeks
Title
triglyceride
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Green Coffee Extract and Metabolic Syndrome

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