Sex-dependent Effects of Flavanols on Vascular Status

April 15, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Division of Cardiology, Pulmonology and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy post-menopausal femal subjects (>50 years)
  • healthy male subjects (>50 years)

Exclusion Criteria:

  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP > 1 mg/dl
  • malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flavanol rich product A
250 mg flavanols
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
Active Comparator: Flavanol rich product B
500 mg flavanols
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
Active Comparator: Flavanol rich product C
750 mg flavanols
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
Placebo Comparator: Flavanol free product
flavanol free
Dietary supplement: Flavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change of Flow-mediated Vasodilation (FMD)
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma flavanol metabolites
Time Frame: 2 hours
Measured by HPLC
2 hours
Pulse wave velocity
Time Frame: 2 hours
Measured by SphygmoCor
2 hours
Ambulatory blood pressure
Time Frame: 2 hours
automatical measurements
2 hours
Augmentation index
Time Frame: 2 hours
Measured by SphygmoCor
2 hours
laboratory safety parameters
Time Frame: 2 hours
blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis)
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
  • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonology and Vascular Medicine
  • Principal Investigator: Ana Rodriguez Mateos, PhD, Division of Cardiology, Pulmonology and Vascular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRANDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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