Clinical trial NCT02764749: Cranberry (Poly)Phenol Consumption on Vascular Function
Official title: Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young
Keywords: vascular function
endothelial function
polyphenols
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change form Baseline Endothelial function at 1 month
timeFrame: 2 hours and 1 month
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: Baseline and 1 month
measure: Blood pressure
timeFrame: Baseline and 1month
measure: high density lipoproteins (HDL)
timeFrame: Baseline and 1 month
measure: low density lipoproteins (LDL)
timeFrame: Baseline and 1 month
measure: triglyceride
timeFrame: Baseline and 1 month
Other outcomes:
measure: Plasma cranberry (poly)phenol metabolites
timeFrame: Baseline and 1 month
measure: Urinary cranberry (poly)phenol metabolites
timeFrame: Baseline and 1 month
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
name: Ana Rodriguez-Mateo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.