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Completed

NCT Number: NCT02517775

Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

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.

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Key information

Conditions

Healthy Men

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cranberry 320

Dietary Supplement

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

Cranberry 640

Dietary Supplement

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

Cranberry 960

Dietary Supplement

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

Cranberry 1280

Dietary Supplement

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

Cranberry 1600

Dietary Supplement

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

Cranberry deprived supplement

Dietary Supplement

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

Primary outcomes

  1. Endothelial function

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

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

Secondary outcomes

  1. pulse wave velocity

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

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

  2. Central blood pressure

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

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

  3. Peripheral blood pressure

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

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

  4. Heart Rate

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

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

Other outcomes

  1. Plasma (poly)phenol metabolites

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

    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

  2. Urinary (poly)phenol metabolites

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

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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • The Cranberry Institute

Registry information

Official study title

Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals

Acronym: Cranberry

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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