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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Blueberry Group; Dietary Supplement: Placebo Group

• Registration Number: NCT02520830
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blueberry Group	Blueberry Group	Dietary Supplement: 22 gram freeze-dried blueberry powder per day
Placebo Group	Placebo Group	blueberry polyphenol deprived powder 22 gram per day

Primary Outcome Measures

Name	Time	Method
Endothelial function	baseline and 1 month	Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	baseline and 1 month	Measured by SphygmoCor 0 and 2 hours postconsumption
Blood lipids	baseline and 1 month	biochemical analysis, 0 and 2 hours postconsumption
Blood pressure	baseline and 1 month	automatical measurements, 0 and 2 hours postconsumption

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany