- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517775
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
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
-
-
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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 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 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 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 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 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)
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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.
Collaborators
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.
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
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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