Effects of Cranberry Consumption in Vascular Function in Healthy Individuals (Cranberry)

November 2, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cranberry 320
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry 320
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Active Comparator: Cranberry 640
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry 640
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Active Comparator: Cranberry 960
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry 960
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Active Comparator: Cranberry 1280
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry 1280
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Active Comparator: Cranberry 1600
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry 1600
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Placebo Comparator: Cranberry deprived supplement
Placebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily)
Dietary supplement: Cranberry deprived supplement
Cranberry deprived supplement Acute intake of 500 mL (1x daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse wave velocity
Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake
Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Central blood pressure
Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake
Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Peripheral blood pressure
Time Frame: 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
Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Heart Rate
Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake
Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma (poly)phenol metabolites
Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0,1, 2, 4, 6, 8 and 24 hours after intake
Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Urinary (poly)phenol metabolites
Time Frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0, 8 and 24 hours after intake
Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

The Cranberry Institute

Investigators

  • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
  • Principal Investigator: Ana Rodriguez-Mateos, PhD, Division of Cardiology, Pulmonology and Vascular Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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