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

NCT ID: NCT02734901

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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400 g frozen raspberries

Red raspberry beverage Acute intake of 600 mL (1x daily)

Group Type ACTIVE_COMPARATOR

400 g frozen raspberries

Intervention Type DIETARY_SUPPLEMENT

1x daily intake of 600 mL red raspberry beverage

200 g frozen raspberries

Red raspberry beverage Acute intake of 600 mL (1x daily)

Group Type ACTIVE_COMPARATOR

200 g frozen raspberries

Intervention Type DIETARY_SUPPLEMENT

1x daily intake of 600 mL red raspberry beverage

Placebo control

Raspberry deprived supplement Acute intake of 600 mL (1x daily)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1x daily intake of 600 mL raspberry deprived supplement

Interventions

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400 g frozen raspberries

1x daily intake of 600 mL red raspberry beverage

Intervention Type DIETARY_SUPPLEMENT

200 g frozen raspberries

1x daily intake of 600 mL red raspberry beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo

1x daily intake of 600 mL raspberry deprived supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Rodriguez-Mateos, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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Istas G, Feliciano RP, Weber T, Garcia-Villalba R, Tomas-Barberan F, Heiss C, Rodriguez-Mateos A. Plasma urolithin metabolites correlate with improvements in endothelial function after red raspberry consumption: A double-blind randomized controlled trial. Arch Biochem Biophys. 2018 Aug 1;651:43-51. doi: 10.1016/j.abb.2018.05.016. Epub 2018 May 24.

Reference Type DERIVED
PMID: 29802820 (View on PubMed)

Other Identifiers

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15-038

Identifier Type: OTHER

Identifier Source: secondary_id

Rapsberry

Identifier Type: -

Identifier Source: org_study_id

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