FindTrial
Sign In

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01130727
Enrollment
51
Registered
2010-05-26
Start date
2010-05-31
Completion date
2012-02-29
Last updated
2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Diabetes Mellitus, Diabetic Nephropathy

Keywords

diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide

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.

Interventions

OTHERgreen tea extract

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

OTHERcocoa extract rich in polyphenols

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

OTHERplacebo

placebo

OTHERlow polyphenol cocoa extract

placebo

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
flow-mediated dilation (FMD)up to 4 hours

Secondary

MeasureTime frame
arterial blood pressure and cardiac rateup to 4 hours
plasma levels of flavonolsup to 4 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026