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Age-dependent Effects of Flavanols on Vascular Status

NCT01639781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-12-16

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. 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Flavanol rich intervention

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

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

Sponsors & Collaborators

  • University of Reading

    collaborator OTHER

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

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 NCT01639781 on ClinicalTrials.gov