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Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism

Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02520830
Enrollment
45
Registered
2015-08-13
Start date
2014-03-31
Completion date
2015-09-30
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

blueberry polyphenols, Polyphenol metabolites, endothelial function, Molecular mechanisms of action, Vascular function, Healthy men

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.

Interventions

DIETARY_SUPPLEMENTBlueberry Group

22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water

DIETARY_SUPPLEMENTPlacebo Group

Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial functionbaseline and 1 monthDetermination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption

Secondary

MeasureTime frameDescription
Pulse wave velocitybaseline and 1 monthMeasured by SphygmoCor 0 and 2 hours postconsumption
Blood pressurebaseline and 1 monthautomatical measurements, 0 and 2 hours postconsumption
Blood lipidsbaseline and 1 monthbiochemical analysis, 0 and 2 hours postconsumption

Other

MeasureTime frameDescription
Plasma blueberry polyphenol metabolitesbaseline and 1 monthmeasured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption
Peripheral blood mononuclear cell-derived gene expression analysisbaseline and 1 monthexploratory measures; measured by Agilent Human GZ 4x44 v2 Microarray

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026