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

Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Blueberry Group; Dietary supplement: Placebo Group

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blueberry Group; Dietary Supplement: 22 gram freeze-dried blueberry powder per day	Dietary supplement: Blueberry 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
Placebo Comparator: Placebo Group; blueberry polyphenol deprived powder 22 gram per day	Dietary supplement: Placebo Group; Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption	baseline and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Measured by SphygmoCor 0 and 2 hours postconsumption	baseline and 1 month
Blood pressure	automatical measurements, 0 and 2 hours postconsumption	baseline and 1 month
Blood lipids	biochemical analysis, 0 and 2 hours postconsumption	baseline and 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma blueberry polyphenol metabolites	measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption	baseline and 1 month
Peripheral blood mononuclear cell-derived gene expression analysis	exploratory measures; measured by Agilent Human GZ 4x44 v2 Microarray	baseline and 1 month

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Ana Rodriguez-Mateos, PhD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf; Study Chair: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: endothelial function; Vascular function; Healthy men; blueberry polyphenols; Polyphenol metabolites; Molecular mechanisms of action
• Other Study ID Numbers: Blueberries