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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130727
First Posted: May 26, 2010
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Jose Butori Lopes de Faria, University of Campinas, Brazil
  Purpose
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 Intervention
Diabetes Mellitus Diabetic Nephropathy Arterial Hypertension Other: green tea extract Other: cocoa extract rich in polyphenols Other: placebo Other: low polyphenol cocoa extract

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jose Butori Lopes de Faria, University of Campinas, Brazil:

Primary Outcome Measures:
  • flow-mediated dilation (FMD) [ Time Frame: up to 4 hours ]

Secondary Outcome Measures:
  • arterial blood pressure and cardiac rate [ Time Frame: up to 4 hours ]
  • plasma levels of flavonols [ Time Frame: up to 4 hours ]

Enrollment: 51
Study Start Date: May 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: green tea extract Other: green tea extract
1.21g of green tea extract (965 mg of flavonols)
Other Name: 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 Name: 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 Name: placebo cocoa extract, Barry Callebaut, Belgium

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130727


Locations
Brazil
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
  More Information

Responsible Party: Jose Butori Lopes de Faria, Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01130727     History of Changes
Other Study ID Numbers: GTCOCOA-01
First Submitted: May 18, 2010
First Posted: May 26, 2010
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by Jose Butori Lopes de Faria, University of Campinas, Brazil:
diabetes mellitus
diabetic nephropathy
hypertension
green tea
cocoa
polyphenol
nitric oxide

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Diabetes Complications