Clinical trial NCT02520830: Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism
Official title: Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: blueberry polyphenols
Polyphenol metabolites
endothelial function
Molecular mechanisms of action
Vascular function
Healthy men
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies.

Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Wild blueberries have gained attention due to their high content of phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular function and health when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of wild blueberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* healthy male subjects without clinical signs or symptoms of cardiovascular disease
* 18-70 years

Exclusion Criteria:

* cardiovascular disease
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C- reactive protein \> 1mg/dl
* malignant disease

Primary outcomes:
measure: Endothelial function
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: baseline and 1 month
measure: Blood pressure
timeFrame: baseline and 1 month
measure: Blood lipids
timeFrame: baseline and 1 month
Other outcomes:
measure: Plasma blueberry polyphenol metabolites
timeFrame: baseline and 1 month
measure: Peripheral blood mononuclear cell-derived gene expression analysis
timeFrame: baseline and 1 month
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: STUDY_CHAIR
References:
citation: Rodriguez-Mateos A, Istas G, Boschek L, Feliciano RP, Mills CE, Boby C, Gomez-Alonso S, Milenkovic D, Heiss C. Circulating Anthocyanin Metabolites Mediate Vascular Benefits of Blueberries: Insights From Randomized Controlled Trials, Metabolomics, and Nutrigenomics. J Gerontol A Biol Sci Med Sci. 2019 Jun 18;74(7):967-976. doi: 10.1093/gerona/glz047.