Clincosm LogoSign in Get a demo

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

Sponsor
University of Campinas, Brazil (Other)
Overall Status
Completed
CT.gov ID
NCT01130727
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
51
Enrollment
1
Location
4
Arms
21.1
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: green tea extract
  • Other: cocoa extract rich in polyphenols
  • Other: placebo
  • Other: low polyphenol cocoa extract
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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: placebo

    Other: placebo
    placebo
    Placebo Comparator: cocoa extract with low polyphenol

    Other: low polyphenol cocoa extract
    placebo
    Other Names:
  • placebo cocoa extract, Barry Callebaut, Belgium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. flow-mediated dilation (FMD) [up to 4 hours]

    Secondary Outcome Measures

    1. arterial blood pressure and cardiac rate [up to 4 hours]

    2. plasma levels of flavonols [up to 4 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Campinas Sao Paulo Brazil 13084-971

    Sponsors and Collaborators

    • University of Campinas, Brazil
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jose Butori Lopes de Faria, Professor, University of Campinas, Brazil
    ClinicalTrials.gov Identifier:
    NCT01130727
    Other Study ID Numbers:
    • GTCOCOA-01
    First Posted:
    May 26, 2010
    Last Update Posted:
    Apr 19, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Jose Butori Lopes de Faria, Professor, University of Campinas, Brazil
    diabetes mellitus
    diabetic nephropathy
    hypertension
    green tea
    cocoa
    polyphenol
    nitric oxide
    Additional relevant MeSH terms:
    Kidney Diseases
    Diabetic Nephropathies
    Hypertension
    Diabetes Mellitus

    Study Results

    No Results Posted as of Apr 19, 2012