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

Primary Purpose

Diabetes Mellitus, Diabetic Nephropathy, Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
green tea extract
cocoa extract rich in polyphenols
placebo
low polyphenol cocoa extract
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

green tea extract

Cocoa extract rich in polyphenols

placebo

cocoa extract with low polyphenol

Arm Description

Outcomes

Primary Outcome Measures

flow-mediated dilation (FMD)

Secondary Outcome Measures

arterial blood pressure and cardiac rate
plasma levels of flavonols

Full Information

First Posted
May 18, 2010
Last Updated
April 17, 2012
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01130727
Brief Title
The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Nephropathy, Arterial Hypertension
Keywords
diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
green tea extract
Arm Type
Active Comparator
Arm Title
Cocoa extract rich in polyphenols
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
cocoa extract with low polyphenol
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
green tea extract
Other Intervention Name(s)
Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD
Intervention Description
1.21g of green tea extract (965 mg of flavonols)
Intervention Type
Other
Intervention Name(s)
cocoa extract rich in polyphenols
Other Intervention Name(s)
Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium
Intervention Description
2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Other
Intervention Name(s)
low polyphenol cocoa extract
Other Intervention Name(s)
placebo cocoa extract, Barry Callebaut, Belgium
Intervention Description
placebo
Primary Outcome Measure Information:
Title
flow-mediated dilation (FMD)
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
arterial blood pressure and cardiac rate
Time Frame
up to 4 hours
Title
plasma levels of flavonols
Time Frame
up to 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose b Lopes de Faria, M.D.
Organizational Affiliation
Universidade Estadual de Campinas, Unicamp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13084-971
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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