Skip to main content
Clinical Trials/NCT04935099
NCT04935099CompletedNot Applicable

The Effects of a Single Dose of Wild Blueberries on Mood and Cognition in Healthy Young Adults: a Randomized, Double-blind, Placebo-controlled, Crossover Study

University of Reading1 site in 1 country33 target enrollmentStarted: May 26, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
Negative interpretation bias

Study Overview

Brief Summary

This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g fresh fruit) can improve mood and cognition in healthy young adults. Blood biomarkers of inflammation and neurotransmitter turnover will be analyzed as well as responses to computer-based cognitive tasks designed to measure verbal memory, executive function, and emotional processing.

Detailed Description

The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, double-blind, placebo-controlled, counterbalanced, crossover design. A total of 30 healthy young adults will consume two drinks: one containing 22 g blueberry powder and the other containing 22 g matched placebo powder in counterbalanced order one week apart. The investigators will assess changes in transient mood, cognitive-emotional function, and serum biomarkers of inflammation, neuroplasticity, and monoamine metabolism from baseline to 2 hours post-ingestion.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •18 to 25 years of age
  • •Willingness to provide blood samples

Exclusion Criteria

  • •Allergy to blueberries or any other Vaccinium species
  • •Diagnosis or symptoms of anxiety, depression, or other mental health conditions
  • •Any medically significant condition (e.g. anemia, gastrointestinal disorders, diabetes)
  • •Use of psychoactive medication or recreational drugs in the last two weeks
  • •Current use of medication that could interact with the intervention (e.g. antibiotics)
  • •Obesity or underweight
  • •Participation in other interventional studies in the last month
  • •Pregnancy or lactation

Arms & Interventions

Blueberry/Placebo

Experimental

In this arm, participants will receive the blueberry intervention first, followed by the placebo one week later.

Intervention: Wild blueberry powder (Dietary Supplement)

Blueberry/Placebo

Experimental

In this arm, participants will receive the blueberry intervention first, followed by the placebo one week later.

Intervention: Placebo powder (Dietary Supplement)

Placebo/Blueberry

Experimental

In this arm, participants will receive the placebo first, followed by the blueberry intervention one week later.

Intervention: Wild blueberry powder (Dietary Supplement)

Placebo/Blueberry

Experimental

In this arm, participants will receive the placebo first, followed by the blueberry intervention one week later.

Intervention: Placebo powder (Dietary Supplement)

Outcomes

Primary Outcomes

Negative interpretation bias

Time Frame: 2 hours post-ingestion

A negative interpretation bias is defined as a tendency to interpret ambiguous information in a consistently threatening or negative manner, thus serving as an objective indicator of affective state. In this task, participants will be asked to categorize facial expressions of anger, happiness, and surprise as either positive or negative. Interpretation bias will be operationalized as the percent of trials in which surprised faces were rated as negative, out of the total number of surprise trials (48 trials).

Global transient mood as measured by PANAS-X

Time Frame: 2 hours post-ingestion

The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) is a validated, self-rated measure of affective state, encompassing two general dimensions (positive and negative affect). These will be calculated separately by adding the values of the individual items (21 positive and 25 negative items). Thus, the scales will range from 0 to 84 points for positive affect and from 0 to 100 for negative affect, with a higher score indicating greater positive or negative affect. Positive affect will be considered the primary measure

Cognitive flexibility (accuracy on post-switch trials)

Time Frame: 2 hours post-ingestion

A task-switching test will be used to assess cognitive performance when switching between two predictable tasks requiring simple numerical decisions. The main outcome of interest is the average accuracy of responses to post-switch trials (those immediately following a switch to a new task).

Delayed verbal memory on RAVLT

Time Frame: 2 hours post-ingestion

The Rey Auditory Verbal Learning Test (RAVLT) is a standard neuropsychological assessment designed to evaluate verbal memory. The participant hears a list of 15 words and is asked to recall as many words as possible. This procedure is repeated five times. The main outcome of interest is the number of correctly recalled words 20 minutes after the last presentation of the list of words (Trial A7).

Serum brain-derived neurotrophic factor (BDNF)

Time Frame: 2 hours post-ingestion

Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).

Global transient mood as measured by PANAS-X

Time Frame: baseline

The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) is a validated, self-rated measure of affective state, encompassing two general dimensions (positive and negative affect). These will be calculated separately by adding the values of the individual items (21 positive and 25 negative items). Thus, the scales will range from 0 to 84 points for positive affect and from 0 to 100 for negative affect, with a higher score indicating greater positive or negative affect. Positive affect will be considered the primary measure.

Negative interpretation bias

Time Frame: baseline

A negative interpretation bias is defined as a tendency to interpret ambiguous information in a consistently threatening or negative manner, thus serving as an objective indicator of affective state. In this task, participants will be asked to categorize facial expressions of anger, happiness, and surprise as either positive or negative. Interpretation bias will be operationalized as the percent of trials in which surprised faces were rated as negative, out of the total number of surprise trials (48 trials).

Cognitive flexibility (accuracy on post-switch trials)

Time Frame: baseline

A task-switching test will be used to assess cognitive performance when switching between two predictable tasks requiring simple numerical decisions. The main outcome of interest is the average accuracy of responses to post-switch trials (those immediately following a switch to a new task).

Delayed verbal memory on RAVLT

Time Frame: baseline

The Rey Auditory Verbal Learning Test (RAVLT) is a standard neuropsychological assessment designed to evaluate verbal memory. The participant hears a list of 15 words and is asked to recall as many words as possible. This procedure is repeated five times. The main outcome of interest is the number of correctly recalled words 20 minutes after the last presentation of the list of words (Trial A7).

Serum brain-derived neurotrophic factor (BDNF)

Time Frame: baseline

Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).

Secondary Outcomes

  • Choice reaction time (remaining trials of task-switching test)(2 hours post-ingestion)
  • Distinct affective states as measured by PANAS-X subscales(2 hours post-ingestion)
  • Reaction time to positive stimuli(2 hours post-ingestion)
  • Recall of interference list on RAVLT(2 hours post-ingestion)
  • Serum monoamine oxidase B (MAO-B) inhibition(2 hours post-ingestion)
  • Reaction time to negative stimuli(2 hours post-ingestion)
  • Attentional bias to emotional information(2 hours post-ingestion)
  • Choice reaction time (post-switch trials)(2 hours post-ingestion)
  • Cognitive flexibility (accuracy on remaining trials of task-switching test)(2 hours post-ingestion)
  • Immediate recall on RAVLT(2 hours post-ingestion)
  • Proactive interference on RAVLT(2 hours post-ingestion)
  • Retroactive interference on RAVLT(2 hours post-ingestion)
  • Final acquisition on RAVLT (Trial 5)(2 hours post-ingestion)
  • Retention on RAVLT(2 hours post-ingestion)
  • Serum interleukin-6 (IL-6)(2 hours post-ingestion)
  • Serum C-reactive protein (CRP)(2 hours post-ingestion)
  • Serum 3,4-dihydroxyphenylglycol (DHPG)(2 hours post-ingestion)
  • Recall of interference list on RAVLT(baseline)
  • Distinct affective states as measured by PANAS-X subscales(baseline)
  • Reaction time to positive stimuli(baseline)
  • Reaction time to negative stimuli(baseline)
  • Attentional bias to emotional information(baseline)
  • Cognitive flexibility (accuracy on remaining trials of task-switching test)(baseline)
  • Choice reaction time (post-switch trials)(baseline)
  • Choice reaction time (remaining trials of task-switching test)(baseline)
  • Final acquisition on RAVLT (Trial 5)(baseline)
  • Immediate recall on RAVLT(baseline)
  • Proactive interference on RAVLT(baseline)
  • Retroactive interference on RAVLT(baseline)
  • Retention on RAVLT(baseline)
  • Serum monoamine oxidase B (MAO-B) inhibition(baseline)
  • Serum 3,4-dihydroxyphenylglycol (DHPG)(baseline)
  • Serum interleukin-6 (IL-6)(baseline)
  • Serum C-reactive protein (CRP)(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof Claire Williams

Professor

University of Reading

Study Sites (1)

Loading locations...

Similar Trials