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Completed

NCT Number: NCT02734901

Effects of Acute Red Raspberry Consumption on 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. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and 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 have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.

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Key information

Conditions

Healthy

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 (no 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
  • raspberry allergy/intolerance
  • hypotension (≤100 / 60 mm Hg)

Treatment and study plan

400 g frozen raspberries

Dietary Supplement

1x daily intake of 600 mL red raspberry beverage

200 g frozen raspberries

Dietary Supplement

1x daily intake of 600 mL red raspberry beverage

Placebo

Dietary Supplement

1x daily intake of 600 mL raspberry deprived supplement

Primary outcomes

  1. Change from baseline to 2 hour and 24 hour in Endothelial function

    Time frame: Baseline, 2 hour and 24 hour

    measured by flow mediated dilation (FMD) on baseline at 2 and 24 hour postconsumption

Secondary outcomes

  1. Change from baseline to 2 hour and 24 hour in Pulse wave velocity

    Time frame: Baseline, 2 hour and 24 hour

    measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption

  2. Change from baseline to 2 hour and 24 hour in Central blood pressure

    Time frame: Baseline, 2 hour and 24 hour

    measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption

  3. Peripheral blood pressure

    Time frame: Baseline, 2 h and 24 h

    measured by automatic sphygmomanometer on baseline at 2 and 24 hours postconsumption

  4. Change from baseline to 2 hour and 24 hour in Heart rate

    Time frame: Baseline, 2 hour and 24 hour

    measured by SphygmoCor on baseline at 2 and 24 hours postconsumption

Other outcomes

  1. Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in blood plasma

    Time frame: Baseline, 2 hour and 24 hour

    measured by ultra-performance liquid chromatography/quadrupole-time-of-flight mass-spectrometry (UPLC-Q-TOF MS ) on baseline at 2 and 24 hours postconsumption

  2. Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in urine

    Time frame: Baseline, 2 hour and 24 hour

    measured by ultra-performance liquid chromatography/quadrupole-time-of-flight mass-spectrometry (UPLC-Q-TOF MS ) on baseline at 2 and 24 hours postconsumption

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Oct 20, 2016

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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