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CompletedNCT02517775CranberryUpdated Nov 3, 2015

Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

An interventional study of Cranberry 320 and Cranberry 640 in Healthy Men, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Men

Keywords

  • polyphenols
  • vascular function
  • endothelial function
  • cranberry
  • healthy
03

In context

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy male subjects without clinical signs or symptoms of cardiovascular disease

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Cranberry 320

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

    Dietary Supplement: Cranberry 320

  • Active comparator
    Cranberry 640

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

    Dietary Supplement: Cranberry 640

  • Active comparator
    Cranberry 960

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

    Dietary Supplement: Cranberry 960

  • Active comparator
    Cranberry 1280

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

    Dietary Supplement: Cranberry 1280

  • Active comparator
    Cranberry 1600

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

    Dietary Supplement: Cranberry 1600

  • Placebo comparator
    Cranberry deprived supplement

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

    Dietary Supplement: Cranberry deprived supplement

Interventions

  • Dietary supplementCranberry 320

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

  • Dietary supplementCranberry 640

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

  • Dietary supplementCranberry 960

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

  • Dietary supplementCranberry 1280

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

  • Dietary supplementCranberry 1600

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

  • Dietary supplementCranberry deprived supplement

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

06

What researchers measure

Primary outcomes

  1. Endothelial function

    measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Secondary outcomes

  1. pulse wave velocity

    measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  2. Central blood pressure

    measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  3. Peripheral blood pressure

    measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  4. Heart Rate

    measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Other outcomes

  1. Plasma (poly)phenol metabolites

    measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0,1, 2, 4, 6, 8 and 24 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  2. Urinary (poly)phenol metabolites

    measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0, 8 and 24 hours after intake

    Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption

07

Study locations

1 site
  • Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
    Duesseldorf, 40225, Germany
08

References and documents

Publications

  • 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. PubMed 34750642 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02517775
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
The Cranberry Institute
Responsible party
Klinik für Kardiologie, Pneumologie und Angiologie (Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf) — Principal investigator
First posted
Aug 7, 2015
Start date
Oct 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Nov 3, 2015

Study contacts

Ana Rodriguez-Mateos, PhD
principal investigator · Division of Cardiology, Pulmonology and Vascular Medicine
Christian Heiss, MD
principal investigator · Division of Cardiology, Pulmonology and Vascular Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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