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Cranberry (Poly)Phenol Consumption on Vascular Function

NCT ID: NCT02764749

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Young

Keywords

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vascular function endothelial function polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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freeze dried powder whole cranberry dissolved in water

Dietary Supplement: freeze dried cranberry powder

Group Type EXPERIMENTAL

cranberry (poly)phenol containing supplement

Intervention Type DIETARY_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.

freeze dried cranberry deprived powder dissolved in water

Placebo comparator: freeze dried cranberry deprived powder

Group Type PLACEBO_COMPARATOR

Placebo comparator: cranberry (poly)phenol deprived supplement

Intervention Type DIETARY_SUPPLEMENT

Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Investigator of Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Rodriguez-Mateo, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35322843 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34750642 (View on PubMed)

Other Identifiers

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15-042

Identifier Type: OTHER

Identifier Source: secondary_id

Cranberry

Identifier Type: -

Identifier Source: org_study_id