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

NCT ID: NCT01130727

Last Updated: 2012-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Diabetic Nephropathy Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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green tea extract

Group Type ACTIVE_COMPARATOR

green tea extract

Intervention Type OTHER

1.21g of green tea extract (965 mg of flavonols)

Cocoa extract rich in polyphenols

Group Type ACTIVE_COMPARATOR

cocoa extract rich in polyphenols

Intervention Type OTHER

2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

cocoa extract with low polyphenol

Group Type PLACEBO_COMPARATOR

low polyphenol cocoa extract

Intervention Type OTHER

placebo

Interventions

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green tea extract

1.21g of green tea extract (965 mg of flavonols)

Intervention Type OTHER

cocoa extract rich in polyphenols

2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols

Intervention Type OTHER

placebo

placebo

Intervention Type OTHER

low polyphenol cocoa extract

placebo

Intervention Type OTHER

Other Intervention Names

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Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium placebo cocoa extract, Barry Callebaut, Belgium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Jose Butori Lopes de Faria

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose b Lopes de Faria, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual de Campinas, Unicamp

Locations

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University Hospital

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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GTCOCOA-01

Identifier Type: -

Identifier Source: org_study_id

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