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Clinical Trials/NCT02517775
NCT02517775
Completed
Not Applicable

Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals

Heinrich-Heine University, Duesseldorf1 site in 1 country10 target enrollmentOctober 2014
ConditionsHealthy Men

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Men
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
10
Locations
1
Primary Endpoint
Endothelial function
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

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

Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

Inclusion Criteria

  • healthy male subjects without clinical signs or symptoms of cardiovascular disease

Exclusion Criteria

  • cardiovascular disease
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • C-reactive protein \> 05 mg/dL
  • malignant disease
  • cranberry allergy/intolerance
  • hypotension (≤100 / 60 mm Hg)

Outcomes

Primary Outcomes

Endothelial function

Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake

Secondary Outcomes

  • Heart Rate(Baseline, on week 1, 2, 3, 4 and 5 postconsumption)
  • pulse wave velocity(Baseline, on week 1, 2, 3, 4 and 5 postconsumption)
  • Central blood pressure(Baseline, on week 1, 2, 3, 4 and 5 postconsumption)
  • Peripheral blood pressure(Baseline, on week 1, 2, 3, 4 and 5 postconsumption)

Study Sites (1)

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