Sex-dependent Effects of Flavanols on Vascular Status

NCT ID: NCT02147223

Last Updated: 2015-04-16

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Flavanol rich product A

250 mg flavanols

Group Type ACTIVE_COMPARATOR

Flavanol rich intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol free intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol rich product B

500 mg flavanols

Group Type ACTIVE_COMPARATOR

Flavanol rich intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol free intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol rich product C

750 mg flavanols

Group Type ACTIVE_COMPARATOR

Flavanol rich intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol free intervention

Intervention Type DIETARY_SUPPLEMENT

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

Flavanol free product

flavanol free

Group Type PLACEBO_COMPARATOR

Flavanol rich intervention

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Flavanol rich intervention

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

Intervention Type DIETARY_SUPPLEMENT

Flavanol free intervention

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

Ana Rodriguez Mateos, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonology and Vascular Medicine

Locations

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Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BRANDED

Identifier Type: -

Identifier Source: org_study_id

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