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Sex-dependent Effects of Flavanols on Vascular Status

NCT02147223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-16

No results posted yet for this study

Summary

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Conditions

Interventions

DIETARY_SUPPLEMENT

Flavanol rich intervention

Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

DIETARY_SUPPLEMENT

Flavanol free intervention

Calorically, micro- and macronutrient matched control product free of flavanols

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Christian Heiss, MD · Division of Cardiology, Pulmonology and Vascular Medicine

  • Ana Rodriguez Mateos, PhD · Division of Cardiology, Pulmonology and Vascular Medicine

  • Malte Kelm, MD · Division of Cardiology, Pulmonology and Vascular Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147223 on ClinicalTrials.gov