Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

NCT ID: NCT02517775

Last Updated: 2015-11-03

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cranberry 320

Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Group Type ACTIVE_COMPARATOR

Cranberry 320

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Cranberry 640

Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Group Type ACTIVE_COMPARATOR

Cranberry 640

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Cranberry 960

Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Group Type ACTIVE_COMPARATOR

Cranberry 960

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Cranberry 1280

Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Group Type ACTIVE_COMPARATOR

Cranberry 1280

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Cranberry 1600

Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Group Type ACTIVE_COMPARATOR

Cranberry 1600

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Cranberry deprived supplement

Placebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Group Type PLACEBO_COMPARATOR

Cranberry deprived supplement

Intervention Type DIETARY_SUPPLEMENT

Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Interventions

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Cranberry 320

Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Cranberry 640

Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Cranberry 960

Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Cranberry 1280

Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Cranberry 1600

Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Cranberry deprived supplement

Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Cranberry Institute

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Rodriguez-Mateos, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

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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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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14-012

Identifier Type: -

Identifier Source: org_study_id

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