NCT03592966

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2018

Longer than P75 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

First Submitted

Initial submission to the registry

April 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

April 6, 2018

Last Update Submit

May 18, 2021

Conditions

Healthy

Keywords

(Poly)phenolsBlueberriesAnthocyaninsCognitive functionVascular function

Outcome Measures

Primary Outcomes (2)

  • Cognitive function

    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).

    Change from baseline cognitive function at 2 hours post-consumption

  • Endothelial Function

    Flow mediated dilation (FMD)

    Change from baseline endothelial function at 2 hours post-consumption

Secondary Outcomes (2)

  • Cerebral blood flow (CBF)

    Change of baseline cerebral blood flow at 2 hours post consumption

  • Blood pressure

    Change from baseline systolic blood pressure at 2 hours post consumption

Other Outcomes (2)

  • Plasma blueberry (poly)phenol metabolites

    2 hours

  • Urine (poly)phenol metabolites

    Baseline and 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Freeze-dried placebo powder

Dietary Supplement: Placebo

Wild Blueberry powder

ACTIVE COMPARATOR

Freeze-dried whole fruit blueberry drink.

Dietary Supplement: Wild Blueberry Powder

Interventions

Wild Blueberry PowderDIETARY_SUPPLEMENT

Freeze-dried whole fruit blueberry drink.

Wild Blueberry powder
PlaceboDIETARY_SUPPLEMENT

Freeze-dried placebo powder

Placebo

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, cross-over, double-blind, placebo-controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2018

First Posted

July 19, 2018

Study Start

June 1, 2018

Primary Completion

October 1, 2020

Study Completion

May 18, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations

GB(1)