Clinical trial NCT02517775: Effects of Cranberry Consumption in Vascular Function in Healthy Individuals
Official title: Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Keywords: polyphenols
vascular function
endothelial function
cranberry
healthy
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: The Cranberry Institute
First posted: 2015-08-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Endothelial function
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Secondary outcomes:
measure: pulse wave velocity
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measure: Central blood pressure
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measure: Peripheral blood pressure
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measure: Heart Rate
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Other outcomes:
measure: Plasma (poly)phenol metabolites
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measure: Urinary (poly)phenol metabolites
timeFrame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
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
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.