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Age-dependent Effects of Flavanols on Vascular Status

NCT ID: NCT01639781

Last Updated: 2014-12-16

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

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-08-31

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. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Detailed Description

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Conditions

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Cardiovascular Diseases

Keywords

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flavanols age related cardiovascular effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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flavanol rich intervention

flavanol rich drink

Group Type ACTIVE_COMPARATOR

Flavanol rich intervention

Intervention Type DIETARY_SUPPLEMENT

Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks

flavanol free intervention

flavanol free drink

Group Type PLACEBO_COMPARATOR

Flavanol free control

Intervention Type DIETARY_SUPPLEMENT

Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks

Interventions

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Flavanol rich intervention

Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks

Intervention Type DIETARY_SUPPLEMENT

Flavanol free control

Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy male participants between 18-35 years
* healthy male participants between 50-80 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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role collaborator

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

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, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27.

Reference Type DERIVED
PMID: 26013912 (View on PubMed)

Other Identifiers

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FLA-111-CH

Identifier Type: OTHER

Identifier Source: secondary_id

AGE-111-CH

Identifier Type: -

Identifier Source: org_study_id