Investigating the Effects of Daily Consumption of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance

NCT04084457 | Completed

• 1 other identifier: BluFlow
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial investigating the effects of daily blueberry (poly)phenol consumption on vascular function and cognitive performance in healthy elderly individuals. The study will be conducted at King's College London, Franklin-Wilkins Building. Eligible subjects will be healthy males and females aged 65-80.

Conditions

Healthy Aging; Healthy

Keywords

polyphenols; Blueberries; cognition; vascular function; vascular health; cognitive function; anthocyanins; flavonoids

Outcome Measures

Primary Outcomes (2)

• Endothelial Function

  Changes in flow-mediated dilation of the brachial artery (FMD) from baseline after 12-week consumption of blueberry vs control

  Baseline and 12 weeks post-intervention

• Cognitive function

  Changes in cognitive function from baseline after 12-week consumption of blueberry vs control. 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 which are Auditory Verbal learning task, Corsi Blocks, Switching task and Serials 3's and 7's, including a mood assessment (PANAS).

  Baseline and 12 weeks post-intervention

Secondary Outcomes (14)

• Cerebral blood flow velocity (CBFv)

  Baseline and 12 weeks post-intervention

• Office systolic blood pressure

  Baseline and 12 weeks post-intervention

• Pulse wave velocity (PWV)

  Baseline and 12 weeks post-intervention

• Augmentation Index (AIx)

  Baseline and 12 weeks post-intervention

• 24-hour ambulatory systolic blood pressure

  Baseline and 12 weeks post-intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched for macronutrients, micronutrients and fibre

Dietary Supplement: Placebo

Wild Blueberry Powder

ACTIVE COMPARATOR

Formulation of a 100% blueberry (freeze-dried whole fruit) drink

Dietary Supplement: Wild Blueberry powder

Interventions

Wild Blueberry powder DIETARY_SUPPLEMENT

Powdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered.

Wild Blueberry Powder

Placebo DIETARY_SUPPLEMENT

Identical formulation as the treatment matched for fibre and vitamin C

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants will include 60 healthy male and female volunteers, aged 65-80.
• Volunteers will be able to understand the nature of the study and able to give signed written informed consent.
• Subjects 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.
• 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 irregularly.
• 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.

Sponsors & Collaborators

• King's College London: lead
• University of Reading: collaborator

Study Sites (1)

Franklin-Wilkins Building, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• Wood E, Hein S, Mesnage R, Fernandes F, Abhayaratne N, Xu Y, Zhang Z, Bell L, Williams C, Rodriguez-Mateos A. Wild blueberry (poly)phenols can improve vascular function and cognitive performance in healthy older individuals: a double-blind randomized controlled trial. Am J Clin Nutr. 2023 Jun;117(6):1306-1319. doi: 10.1016/j.ajcnut.2023.03.017. Epub 2023 Mar 25.

  PMID: 36972800 DERIVED

Study Officials

• Ana Rodriguez-Mateos, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 10, 2019
• Study Start: September 4, 2019
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

GB (1)