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 :
Completed
First Posted : July 19, 2018
Last Update Posted : May 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Dietary Supplement: Wild Blueberry Powder Dietary Supplement: Placebo | Not Applicable |
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 |

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. |
- 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).
- Endothelial Function [ Time Frame: Change from baseline endothelial function at 2 hours post-consumption ]Flow mediated dilation (FMD)
- 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)
- Blood pressure [ Time Frame: Change from baseline systolic blood pressure at 2 hours post consumption ]Automated clinical digital sphygmomanometer
- Plasma blueberry (poly)phenol metabolites [ Time Frame: 2 hours ]Measured by liquid chromotography- mass spectrometry (LC/MS)
- Urine (poly)phenol metabolites [ Time Frame: Baseline and 12 weeks ]24-hour urine samples

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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 |
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.

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
United Kingdom | |
King's College London | |
London, United Kingdom, SE1 9NH |
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 Key Record Dates |
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 |
(Poly)phenols Blueberries Anthocyanins Cognitive function Vascular function |