The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus

April 17, 2012 updated by: Jose Butori Lopes de Faria, University of Campinas, Brazil

Randomized Clinical Trial, Placebo Controlled, With Parallel Groups to Investigate Whether Green Tea or Cocoa Extracts Improves Endothelial Dysfunction in Patients With Diabetes Mellitus and Nephropathy and Hypertension

The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13084-971
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus
  • Diabetic nephropathy
  • Hypertension

Exclusion Criteria:

  • GFR < 30 ml/min/1.73m2
  • Serum K > 5.5 mEq/L
  • Age < 18 y
  • Pregnancy
  • Breast feeding
  • Cocoa or green tea intolerance
  • Alcohol and drugs abuse
  • Incapacity to understand the information related to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
placebo
Active Comparator: green tea extract
Other: green tea extract
1.21g of green tea extract (965 mg of flavonols)
Other Names:
  • Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD
Active Comparator: Cocoa extract rich in polyphenols
Other: cocoa extract rich in polyphenols
2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
Other Names:
  • Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium
Placebo Comparator: cocoa extract with low polyphenol
Other: low polyphenol cocoa extract
placebo
Other Names:
  • placebo cocoa extract, Barry Callebaut, Belgium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
flow-mediated dilation (FMD)
Time Frame: up to 4 hours
up to 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
arterial blood pressure and cardiac rate
Time Frame: up to 4 hours
up to 4 hours
plasma levels of flavonols
Time Frame: up to 4 hours
up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Jose b Lopes de Faria, M.D., Universidade Estadual de Campinas, Unicamp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTCOCOA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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