Cranberry (Poly)Phenol Consumption on Vascular Function

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Young
• Intervention / Treatment: Dietary supplement: cranberry (poly)phenol containing supplement; Dietary supplement: Placebo comparator: cranberry (poly)phenol deprived supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: freeze dried powder whole cranberry dissolved in water; Dietary Supplement: freeze dried cranberry powder	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: freeze dried cranberry deprived powder dissolved in water; Placebo comparator: freeze dried cranberry deprived powder	Dietary supplement: Placebo comparator: cranberry (poly)phenol deprived supplement; Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change form Baseline Endothelial function at 1 month	Measured by Flow mediated dilation (FMD)	2 hours and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Measured by SphygmoCor 0 and 2 hours postconsumption	Baseline and 1 month
Blood pressure	automatical measurements 0 and 2 hours postconsumption	Baseline and 1month
high density lipoproteins (HDL)	measured on baseline and after 1 month	Baseline and 1 month
low density lipoproteins (LDL)	measured on baseline and after 1 month	Baseline and 1 month
triglyceride	measured on baseline and after 1 month	Baseline and 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma cranberry (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption	Baseline and 1 month
Urinary cranberry (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption	Baseline and 1 month

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Ana Rodriguez-Mateo, PhD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Publications and helpful links

General Publications

• Heiss C, Istas G, Feliciano RP, Weber T, Wang B, Favari C, Mena P, Del Rio D, Rodriguez-Mateos A. Daily consumption of cranberry improves endothelial function in healthy adults: a double blind randomized controlled trial. Food Funct. 2022 Apr 4;13(7):3812-3824. doi: 10.1039/d2fo00080f.
• Mena P, Favari C, Acharjee A, Chernbumroong S, Bresciani L, Curti C, Brighenti F, Heiss C, Rodriguez-Mateos A, Del Rio D. Metabotypes of flavan-3-ol colonic metabolites after cranberry intake: elucidation and statistical approaches. Eur J Nutr. 2022 Apr;61(3):1299-1317. doi: 10.1007/s00394-021-02692-z. Epub 2021 Nov 9.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 24, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: vascular function; polyphenols; endothelial function
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Phenol
• Other Study ID Numbers: Cranberry; 15-042 (Other Identifier: CTSU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No