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Clinical Trials/NCT02734901
NCT02734901
Completed
Not Applicable

Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals

Heinrich-Heine University, Duesseldorf1 site in 1 country10 target enrollmentMarch 2016
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
10
Locations
1
Primary Endpoint
Change from baseline to 2 hour and 24 hour in Endothelial function
Status
Completed
Last Updated
9 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Change from baseline to 2 hour and 24 hour in Pulse wave velocity(Baseline, 2 hour and 24 hour)
  • Change from baseline to 2 hour and 24 hour in Heart rate(Baseline, 2 hour and 24 hour)
  • Change from baseline to 2 hour and 24 hour in Central blood pressure(Baseline, 2 hour and 24 hour)
  • Peripheral blood pressure(Baseline, 2 h and 24 h)

Study Sites (1)

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