Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

Not Applicable

Completed

• Conditions: Healthy Men

• Registration Number: NCT02517775
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial function	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 Outcome Measures

Name	Time	Method
Heart Rate	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake
pulse wave velocity	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake
Central blood pressure	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake
Peripheral blood pressure	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany