NCT02520830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

July 8, 2015

Last Update Submit

November 2, 2015

Conditions

Healthy

Keywords

blueberry polyphenolsPolyphenol metabolitesendothelial functionMolecular mechanisms of actionVascular functionHealthy men

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption

    baseline and 1 month

Secondary Outcomes (3)

  • Pulse wave velocity

    baseline and 1 month

  • Blood pressure

    baseline and 1 month

  • Blood lipids

    baseline and 1 month

Other Outcomes (2)

  • Plasma blueberry polyphenol metabolites

    baseline and 1 month

  • Peripheral blood mononuclear cell-derived gene expression analysis

    baseline and 1 month

Study Arms (2)

Blueberry Group

ACTIVE COMPARATOR

Dietary Supplement: 22 gram freeze-dried blueberry powder per day

Dietary Supplement: Blueberry Group

Placebo Group

PLACEBO COMPARATOR

blueberry polyphenol deprived powder 22 gram per day

Dietary Supplement: Placebo Group

Interventions

Blueberry GroupDIETARY_SUPPLEMENT

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

Blueberry Group
Placebo GroupDIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male subjects without clinical signs or symptoms of cardiovascular disease
  • years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30772905DERIVED

Study Officials

  • Ana Rodriguez-Mateos, PhD

    Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ana Rodriguez Mateos

Study Record Dates

First Submitted

July 8, 2015

First Posted

August 13, 2015

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

DE(1)