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Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognition in Healthy Individuals. (BluLife)

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ClinicalTrials.gov Identifier: NCT03592966
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
University of Reading
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

Study Description
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Brief Summary:
This study aims to determine the effect of blueberry (poly)phenol vs placebo on vascular function and cognitive performance with an insight into cerebral blood flow velocity changes, across all ages of the general healthy population.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Wild Blueberry Powder Dietary Supplement: Placebo Not Applicable

Detailed Description:
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. Blueberries are rich in anthocyanins, a subclass of flavonoids that have been widely linked to health benefits, particularly improvements in endothelial function. Research have previously shown that blueberries improve executive functioning and memory in both healthy adults and children. These improvements were seen within 2-5 hours post-consumption of blueberries, a time-course that positively correlates with improvements in vascular function (measured as flow-mediated dilation). This indicates that increases in blood flow may influence improvements in cognitive performance. To date no study has investigated whether blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, investigators aim to directly link wild blueberry consumption with increased vascular and cerebral blood flow and positive cognitive outcomes in healthy individuals through the life course, between the ages of 8 and 80 years old. Investigators will use a large group of healthy subjects representative of the general public over a wide age range in males and females to evaluate the generalisability of the health benefits of blueberry consumption.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, cross-over, double-blind, placebo-controlled study.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomised, Double-blind, Placebo Controlled, Crossover Trial Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance in Healthy Individuals Across the Life Course.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Freeze-dried placebo powder
 Dietary Supplement: Placebo
Freeze-dried placebo powder
Active Comparator: Wild Blueberry powder
Freeze-dried whole fruit blueberry drink.
 Dietary Supplement: Wild Blueberry Powder
Freeze-dried whole fruit blueberry drink.


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive function [ Time Frame: Change from baseline cognitive function at 2 hours post-consumption ]
    Cognitive testing involves the participant conducting tasks administered on a tablet-style laptop. The participants will be conducting these tasks whilst cerebral blood flow measurements are taking place. The cognitive testing battery will consist of 4 tasks including a mood assessment (PANAS).

  2. Endothelial Function [ Time Frame: Change from baseline endothelial function at 2 hours post-consumption ]
    Flow mediated dilation (FMD)


Secondary Outcome Measures :
  1. Cerebral blood flow (CBF) [ Time Frame: Change of baseline cerebral blood flow at 2 hours post consumption ]
    Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD)

  2. Blood pressure [ Time Frame: Change from baseline systolic blood pressure at 2 hours post consumption ]
    Automated clinical digital sphygmomanometer


Other Outcome Measures:
  1. Plasma blueberry (poly)phenol metabolites [ Time Frame: 2 hours ]
    Measured by liquid chromotography- mass spectrometry (LC/MS)

  2. Urine (poly)phenol metabolites [ Time Frame: 24-hours ]
    24-hour urine samples


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy men and women aged 8-80 years old
  • Are able to understand the nature of the study
  • Able and willing to give signed written informed consent with the addition of a parent/carer for the consent of children under 16.
  • Are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.

Exclusion Criteria:

  • Manifest cardiovascular diseases including coronary artery disease, cerebrovascular disease and peripheral artery disease.
  • Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
  • Obese participants, defined as BMI superior or equal to 30.
  • Diabetes mellitus and metabolic syndrome.
  • Acute inflammation, terminal renal failure or malignancies.
  • Abnormal heart rhythm (lower or higher than 60-100 bpm).
  • Allergies to berries or another significant food allergy.
  • Subjects under medication or on vitamin/dietary supplements (within 2 weeks of baseline).
  • Subjects who have lost more than 10% of their weight in the past 6 months or are currently on a diet.
  • Subjects who reported participant in another study within one month before the study starts.
  • Subjects who smoke cigarettes.
  • MCI or dyslexic or unable to complete the cognitive function tasks for any reason such as visual impairments.
  • Subjects who require chronic antimicrobial or antiviral treatment.
  • Subjects with unstable psychological condition.
  • Subjects with history of cancer, myocardial infarction, cerebrovascular incident.
  • Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592966


Contacts
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Contact: Ana Rodriguez-Mateos, PhD +44 (0)20 7848 4349 ana.rodriguez-mateos@kcl.ac.uk
Contact: Claire Williams, PhD +4401183787540 claire.williams@reading.ac.uk

Locations
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United Kingdom
King's College London Recruiting
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
University of Reading
More Information
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Responsible Party: Dr Ana Rodriguez-Mateos, Principal Investigator, King's College London
ClinicalTrials.gov Identifier: NCT03592966     History of Changes
Other Study ID Numbers: TBC
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
(Poly)phenols
Blueberries
Anthocyanins
Cognitive function
Vascular function

Additional relevant MeSH terms:
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Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
 Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions