Clinical trial NCT02734901: Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals
Official title: Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: polyphenols
vascular function
endothelial function
raspberry
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change from baseline to 2 hour and 24 hour in Endothelial function
timeFrame: Baseline, 2 hour and 24 hour
Secondary outcomes:
measure: Change from baseline to 2 hour and 24 hour in Pulse wave velocity
timeFrame: Baseline, 2 hour and 24 hour
measure: Change from baseline to 2 hour and 24 hour in Central blood pressure
timeFrame: Baseline, 2 hour and 24 hour
measure: Peripheral blood pressure
timeFrame: Baseline, 2 h and 24 h
measure: Change from baseline to 2 hour and 24 hour in Heart rate
timeFrame: Baseline, 2 hour and 24 hour
Other outcomes:
measure: Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in blood plasma
timeFrame: Baseline, 2 hour and 24 hour
measure: Change from baseline to 2 hour and 24 hour in Polyphenol metabolites in urine
timeFrame: Baseline, 2 hour and 24 hour
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.