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

• ClinicalTrials.gov Identifier: NCT03592966
• Recruitment Status: Completed
• First Posted: July 19, 2018
• Last Update Posted: May 19, 2021
• Sponsor: King's College London
• Collaborator: University of Reading
• Information provided by (Responsible Party): Dr Ana Rodriguez-Mateos, King's College London

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 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
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

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

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: Baseline and 12 weeks ]
   24-hour urine samples

Eligibility Criteria

• 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

Locations

United Kingdom

King's College London

London, United Kingdom, SE1 9NH

Sponsors and Collaborators

King's College London

University of Reading

More Information

• Responsible Party: Dr Ana Rodriguez-Mateos, Principal Investigator, King's College London
• ClinicalTrials.gov Identifier: NCT03592966
• Other Study ID Numbers: BLULIFE
• First Posted: July 19, 2018
• Last Update Posted: May 19, 2021
• Last Verified: May 2021

• 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