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Clinical Trials/NCT01799005
NCT01799005
Completed
Not Applicable

Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

Heinrich-Heine University, Duesseldorf1 site in 1 country100 target enrollmentFebruary 2013
ConditionsVascular Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Health
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
100
Locations
1
Primary Endpoint
Endothelial function
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
August 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

PD Dr. med. Christian Heiss

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

Inclusion Criteria

  • male, age 35-60 years, healthy
  • female, age 35-60 years, healthy

Exclusion Criteria

  • diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)

Outcomes

Primary Outcomes

Endothelial function

Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

Secondary Outcomes

  • Plasma lipids(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
  • Blood pressure(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
  • Glucose(Time points: day 0 [baseline], and day 30 each 0 and 2h.)

Study Sites (1)

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