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

October 19, 2016 updated by: Heinrich-Heine University, Duesseldorf
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 400 g frozen raspberries
Red raspberry beverage Acute intake of 600 mL (1x daily)
Dietary supplement: 400 g frozen raspberries
1x daily intake of 600 mL red raspberry beverage
Active Comparator: 200 g frozen raspberries
Red raspberry beverage Acute intake of 600 mL (1x daily)
Dietary supplement: 200 g frozen raspberries
1x daily intake of 600 mL red raspberry beverage
Placebo Comparator: Placebo control
Raspberry deprived supplement Acute intake of 600 mL (1x daily)
Dietary supplement: Placebo
1x daily intake of 600 mL raspberry deprived supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 hour and 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 hour and 24 hour
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
Baseline, 2 hour and 24 hour
Peripheral blood pressure
Time Frame: Baseline, 2 h and 24 h
measured by automatic sphygmomanometer on baseline at 2 and 24 hours postconsumption
Baseline, 2 h and 24 h
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
Baseline, 2 hour and 24 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 hour and 24 hour
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
Baseline, 2 hour and 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Ana Rodriguez-Mateos, PhD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Rapsberry
  • 15-038 (CTSU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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