Cranberry (Poly)Phenol Consumption on Vascular Function

Healthy Young Clinical Trial

Official title:

Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764749
• Other study ID #: Cranberry
• Secondary ID: 15-042
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: November 24, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy male subjects (no clinical signs or symptoms of CVD)

• Young >18 years, <35 years

Exclusion Criteria:

• CVD

• acute inflammation

• cardiac arrhythmia

• renal failure

• heart failure (NYHA II-IV)

• diabetes mellitus

• CRP > 1 mg/dl

• malignant disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Young

Intervention

Dietary Supplement:
• cranberry (poly)phenol containing supplement
Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.
• Placebo comparator: cranberry (poly)phenol deprived supplement
Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma cranberry (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption	Baseline and 1 month	No
Other	Urinary cranberry (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption	Baseline and 1 month	No
Primary	Change form Baseline Endothelial function at 1 month	Measured by Flow mediated dilation (FMD)	2 hours and 1 month	No
Secondary	Pulse wave velocity	Measured by SphygmoCor 0 and 2 hours postconsumption	Baseline and 1 month	No
Secondary	Blood pressure	automatical measurements 0 and 2 hours postconsumption	Baseline and 1month	No
Secondary	high density lipoproteins (HDL)	measured on baseline and after 1 month	Baseline and 1 month	No
Secondary	low density lipoproteins (LDL)	measured on baseline and after 1 month	Baseline and 1 month	No
Secondary	triglyceride	measured on baseline and after 1 month	Baseline and 1 month	No