NCT02764957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

May 1, 2016

Last Update Submit

August 25, 2017

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • fasting blood glucose

    8 weeks

Secondary Outcomes (5)

  • HOMA-IR

    8 weeks

  • blood pressure

    8 weeks

  • insulin

    8 weeks

  • hemoglubin A1c

    8 weeks

  • triglyceride

    8 weeks

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

Dietary Supplement: green coffee extract

control

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

green coffee extractDIETARY_SUPPLEMENT
intervention
placeboDIETARY_SUPPLEMENT
control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Insulin administration
  • Pregnancy and breastfeeding
  • regular consumption of coffee and green tea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NNFTRI clinic

Tehran, 19435, Iran

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Azita Hekmatdoost

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 6, 2016

Study Start

December 1, 2016

Primary Completion

March 21, 2017

Study Completion

April 21, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

IR(1)