AzTrials
AzTrials

MoodNCT04935099

The Effects of a Single Dose of Wild Blueberries on Mood and Cognition in Healthy Young Adults

A study testing Wild blueberry powder in people with Mood and Affect, run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Mood, Affect, Cognition
What is being tested?
Wild blueberry powder
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited Kingdom
Study dates
26 May 2021to 27 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • School of Psychology and Clinical Languages, University of Reading

    Reading, Berkshire, RG6 6AL

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the 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.

Conditions
Mood, Affect, Cognition
Being tested
Wild blueberry powder, Placebo powder
Keywords
blueberry, anthocyanins, flavonoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wild blueberry powderDietary supplement

    22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder, mixed with 250 ml water, and served in an opaque container.

  • Placebo powderDietary supplement

    22 g placebo powder matched for macronutrients and flavor, mixed with 250 ml water, and served in an opaque container.

Study groups in NCT04935099
Study groupRoleWhat they receive
Blueberry/PlaceboExperimentalIn this arm, participants will receive the blueberry intervention first, followed by the placebo one week later.
Receives: Dietary Supplement: Wild blueberry powder; Dietary Supplement: Placebo powder
Placebo/BlueberryExperimentalIn this arm, participants will receive the placebo first, followed by the blueberry intervention one week later.
Receives: Dietary Supplement: Wild blueberry powder; Dietary Supplement: Placebo powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global transient mood as measured by PANAS-X

    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.

    Measured: baseline

  2. Global transient mood as measured by PANAS-X

    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

    Measured: 2 hours post-ingestion

  3. Negative interpretation bias

    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).

    Measured: baseline

  4. Negative interpretation bias

    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).

    Measured: 2 hours post-ingestion

  5. Cognitive flexibility (accuracy on post-switch trials)

    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).

    Measured: baseline

  6. Cognitive flexibility (accuracy on post-switch trials)

    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).

    Measured: 2 hours post-ingestion

  7. Delayed verbal memory on RAVLT

    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).

    Measured: baseline

  8. Delayed verbal memory on RAVLT

    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).

    Measured: 2 hours post-ingestion

  9. Serum brain-derived neurotrophic factor (BDNF)

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

    Measured: baseline

  10. Serum brain-derived neurotrophic factor (BDNF)

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

    Measured: 2 hours post-ingestion

Secondary outcomes (34)
  1. Distinct affective states as measured by PANAS-X subscales

    The following affective states will be examined separately as defined by the PANAS-X subscales: Joviality (Happiness), Self-Assurance, Attentiveness, Fatigue, Serenity. Higher scores will indicate greater intensity of the respective affective state.

    Measured: baseline

  2. Distinct affective states as measured by PANAS-X subscales

    The following affective states will be examined separately as defined by the PANAS-X subscales: Joviality (Happiness), Self-Assurance, Attentiveness, Fatigue, Serenity. Higher scores will indicate greater intensity of the respective affective state.

    Measured: 2 hours post-ingestion

  3. Reaction time to positive stimuli

    The average reaction time to correctly categorized happy faces in the facial expression task.

    Measured: baseline

  4. Reaction time to positive stimuli

    The average reaction time to correctly categorized happy faces in the facial expression task.

    Measured: 2 hours post-ingestion

  5. Reaction time to negative stimuli

    The average reaction time to correctly categorized angry faces in the facial expression task.

    Measured: baseline

  6. Reaction time to negative stimuli

    The average reaction time to correctly categorized angry faces in the facial expression task.

    Measured: 2 hours post-ingestion

  7. Attentional bias to emotional information

    Attentional bias to emotional information will be operationalized as the average reaction time to correctly categorized angry faces divided by the average reaction time to correctly categorized happy faces. Thus, a higher value indicates a tendency to attend to and process positive information over negative information.

    Measured: baseline

  8. Attentional bias to emotional information

    Attentional bias to emotional information will be operationalized as the average reaction time to correctly categorized angry faces divided by the average reaction time to correctly categorized happy faces. Thus, a higher value indicates a tendency to attend to and process positive information over negative information.

    Measured: 2 hours post-ingestion

  9. Cognitive flexibility (accuracy on remaining trials of task-switching test)

    The average accuracy (in %) of responses to the remaining trials of the task-switching test will be measured as a secondary outcome. In this task, participants have to switch between two predictable tasks requiring simple numerical decisions.

    Measured: baseline

  10. Cognitive flexibility (accuracy on remaining trials of task-switching test)

    The average accuracy (in %) of responses to the remaining trials of the task-switching test will be measured as a secondary outcome. In this task, participants have to switch between two predictable tasks requiring simple numerical decisions.

    Measured: 2 hours post-ingestion

  11. Choice reaction time (post-switch trials)

    The average reaction time of correct responses to post-switch trials of the task-switching test.

    Measured: baseline

  12. Choice reaction time (post-switch trials)

    The average reaction time of correct responses to post-switch trials of the task-switching test.

    Measured: 2 hours post-ingestion

  13. Choice reaction time (remaining trials of task-switching test)

    The average reaction time of correct responses to remaining trials of the task-switching test.

    Measured: baseline

  14. Choice reaction time (remaining trials of task-switching test)

    The average reaction time of correct responses to remaining trials of the task-switching test.

    Measured: 2 hours post-ingestion

  15. Final acquisition on RAVLT (Trial 5)

    The number of correctly retrieved words on Trial 5 (List A) of the Rey Auditory Verbal Learning Test.

    Measured: baseline

  16. Final acquisition on RAVLT (Trial 5)

    The number of correctly retrieved words on Trial 5 (List A) of the Rey Auditory Verbal Learning Test.

    Measured: 2 hours post-ingestion

  17. Recall of interference list on RAVLT

    The number of correctly retrieved words from the interference list (List B) of the Rey Auditory Verbal Learning Test.

    Measured: baseline

  18. Recall of interference list on RAVLT

    The number of correctly retrieved words from the interference list (List B) of the Rey Auditory Verbal Learning Test.

    Measured: 2 hours post-ingestion

  19. Immediate recall on RAVLT

    The number of correctly recalled words on the Rey Auditory Verbal Learning Test 2 minutes after the final presentation of List A (and following the presentation and recall of List B).

    Measured: baseline

  20. Immediate recall on RAVLT

    The number of correctly recalled words on the Rey Auditory Verbal Learning Test 2 minutes after the final presentation of List A (and following the presentation and recall of List B).

    Measured: 2 hours post-ingestion

  21. Proactive interference on RAVLT

    Proactive interference on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words from the interference List B divided by the number of correctly recalled words on Trial 1 of List A (B1/A1). A higher score indicates less proactive interference.

    Measured: baseline

  22. Proactive interference on RAVLT

    Proactive interference on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words from the interference List B divided by the number of correctly recalled words on Trial 1 of List A (B1/A1). A higher score indicates less proactive interference.

    Measured: 2 hours post-ingestion

  23. Retroactive interference on RAVLT

    Retroactive interference on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words on Trial 6 of List A (the free recall trial after the interference List B) divided by the number of correctly recalled words on Trial 5 of List A (A6/A5). A higher score indicates less retroactive interference.

    Measured: baseline

  24. Retroactive interference on RAVLT

    Retroactive interference on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words on Trial 6 of List A (the free recall trial after the interference List B) divided by the number of correctly recalled words on Trial 5 of List A (A6/A5). A higher score indicates less retroactive interference.

    Measured: 2 hours post-ingestion

  25. Retention on RAVLT

    Retention on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words on Trial 7 of List A (the delayed recall trial at 20 minutes) divided by the number of correctly retrieved words on Trial 6 of List A (A7/A6). Thus, a higher score indicates a higher retention rate.

    Measured: baseline

  26. Retention on RAVLT

    Retention on the Rey Auditory Verbal Learning Test is defined as the number of correctly recalled words on Trial 7 of List A (the delayed recall trial at 20 minutes) divided by the number of correctly retrieved words on Trial 6 of List A (A7/A6). Thus, a higher score indicates a higher retention rate.

    Measured: 2 hours post-ingestion

  27. Serum monoamine oxidase B (MAO-B) inhibition

    The activity of the enzyme MAO-B in serum will be analyzed using a fluorometric assay.

    Measured: baseline

  28. Serum monoamine oxidase B (MAO-B) inhibition

    The activity of the enzyme MAO-B in serum will be analyzed using a fluorometric assay.

    Measured: 2 hours post-ingestion

  29. Serum 3,4-dihydroxyphenylglycol (DHPG)

    Serum levels of DHPG will be analyzed using liquid chromatography-mass spectrometry (LS-MS) to indirectly determine monoamine oxidase A (MAO-A) activity.

    Measured: baseline

  30. Serum 3,4-dihydroxyphenylglycol (DHPG)

    Serum levels of DHPG will be analyzed using liquid chromatography-mass spectrometry (LS-MS) to indirectly determine monoamine oxidase A (MAO-A) activity.

    Measured: 2 hours post-ingestion

  31. Serum interleukin-6 (IL-6)

    Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.

    Measured: baseline

  32. Serum interleukin-6 (IL-6)

    Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.

    Measured: 2 hours post-ingestion

  33. Serum C-reactive protein (CRP)

    Serum levels of CRP will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.

    Measured: baseline

  34. Serum C-reactive protein (CRP)

    Serum levels of CRP will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.

    Measured: 2 hours post-ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start26 May 2021
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04935099
Sponsor's protocol ID
21/09
Status last verified
Sep 2021
First submitted
27 May 2021
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Wild blueberry powder in people with Mood and Affect, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global transient mood as measured by PANAS-X (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in