- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04935099
The Effects of a Single Dose of Wild Blueberries on Mood and Cognition in Healthy Young Adults
September 20, 2021 updated by: Prof Claire Williams, University of Reading
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6AL
- School of Psychology and Clinical Languages, University of Reading
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blueberry/Placebo
In this arm, participants will receive the blueberry intervention first, followed by the placebo one week later.
|
22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder, mixed with 250 ml water, and served in an opaque container.
22 g placebo powder matched for macronutrients and flavor, mixed with 250 ml water, and served in an opaque container.
|
|
Experimental: Placebo/Blueberry
In this arm, participants will receive the placebo first, followed by the blueberry intervention one week later.
|
22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder, mixed with 250 ml water, and served in an opaque container.
22 g placebo powder matched for macronutrients and flavor, mixed with 250 ml water, and served in an opaque container.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
|
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
|
2 hours post-ingestion
|
|
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).
|
baseline
|
|
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).
|
2 hours post-ingestion
|
|
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).
|
baseline
|
|
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).
|
2 hours post-ingestion
|
|
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).
|
baseline
|
|
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).
|
2 hours post-ingestion
|
|
Serum brain-derived neurotrophic factor (BDNF)
Time Frame: baseline
|
Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).
|
baseline
|
|
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).
|
2 hours post-ingestion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distinct affective states as measured by PANAS-X subscales
Time Frame: baseline
|
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.
|
baseline
|
|
Distinct affective states as measured by PANAS-X subscales
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Reaction time to positive stimuli
Time Frame: baseline
|
The average reaction time to correctly categorized happy faces in the facial expression task.
|
baseline
|
|
Reaction time to positive stimuli
Time Frame: 2 hours post-ingestion
|
The average reaction time to correctly categorized happy faces in the facial expression task.
|
2 hours post-ingestion
|
|
Reaction time to negative stimuli
Time Frame: baseline
|
The average reaction time to correctly categorized angry faces in the facial expression task.
|
baseline
|
|
Reaction time to negative stimuli
Time Frame: 2 hours post-ingestion
|
The average reaction time to correctly categorized angry faces in the facial expression task.
|
2 hours post-ingestion
|
|
Attentional bias to emotional information
Time Frame: baseline
|
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.
|
baseline
|
|
Attentional bias to emotional information
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Cognitive flexibility (accuracy on remaining trials of task-switching test)
Time Frame: baseline
|
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.
|
baseline
|
|
Cognitive flexibility (accuracy on remaining trials of task-switching test)
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Choice reaction time (post-switch trials)
Time Frame: baseline
|
The average reaction time of correct responses to post-switch trials of the task-switching test.
|
baseline
|
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Choice reaction time (post-switch trials)
Time Frame: 2 hours post-ingestion
|
The average reaction time of correct responses to post-switch trials of the task-switching test.
|
2 hours post-ingestion
|
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Choice reaction time (remaining trials of task-switching test)
Time Frame: baseline
|
The average reaction time of correct responses to remaining trials of the task-switching test.
|
baseline
|
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Choice reaction time (remaining trials of task-switching test)
Time Frame: 2 hours post-ingestion
|
The average reaction time of correct responses to remaining trials of the task-switching test.
|
2 hours post-ingestion
|
|
Final acquisition on RAVLT (Trial 5)
Time Frame: baseline
|
The number of correctly retrieved words on Trial 5 (List A) of the Rey Auditory Verbal Learning Test.
|
baseline
|
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Final acquisition on RAVLT (Trial 5)
Time Frame: 2 hours post-ingestion
|
The number of correctly retrieved words on Trial 5 (List A) of the Rey Auditory Verbal Learning Test.
|
2 hours post-ingestion
|
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Recall of interference list on RAVLT
Time Frame: baseline
|
The number of correctly retrieved words from the interference list (List B) of the Rey Auditory Verbal Learning Test.
|
baseline
|
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Recall of interference list on RAVLT
Time Frame: 2 hours post-ingestion
|
The number of correctly retrieved words from the interference list (List B) of the Rey Auditory Verbal Learning Test.
|
2 hours post-ingestion
|
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Immediate recall on RAVLT
Time Frame: baseline
|
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).
|
baseline
|
|
Immediate recall on RAVLT
Time Frame: 2 hours post-ingestion
|
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).
|
2 hours post-ingestion
|
|
Proactive interference on RAVLT
Time Frame: baseline
|
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.
|
baseline
|
|
Proactive interference on RAVLT
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Retroactive interference on RAVLT
Time Frame: baseline
|
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.
|
baseline
|
|
Retroactive interference on RAVLT
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Retention on RAVLT
Time Frame: baseline
|
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.
|
baseline
|
|
Retention on RAVLT
Time Frame: 2 hours post-ingestion
|
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.
|
2 hours post-ingestion
|
|
Serum monoamine oxidase B (MAO-B) inhibition
Time Frame: baseline
|
The activity of the enzyme MAO-B in serum will be analyzed using a fluorometric assay.
|
baseline
|
|
Serum monoamine oxidase B (MAO-B) inhibition
Time Frame: 2 hours post-ingestion
|
The activity of the enzyme MAO-B in serum will be analyzed using a fluorometric assay.
|
2 hours post-ingestion
|
|
Serum 3,4-dihydroxyphenylglycol (DHPG)
Time Frame: baseline
|
Serum levels of DHPG will be analyzed using liquid chromatography-mass spectrometry (LS-MS) to indirectly determine monoamine oxidase A (MAO-A) activity.
|
baseline
|
|
Serum 3,4-dihydroxyphenylglycol (DHPG)
Time Frame: 2 hours post-ingestion
|
Serum levels of DHPG will be analyzed using liquid chromatography-mass spectrometry (LS-MS) to indirectly determine monoamine oxidase A (MAO-A) activity.
|
2 hours post-ingestion
|
|
Serum interleukin-6 (IL-6)
Time Frame: baseline
|
Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.
|
baseline
|
|
Serum interleukin-6 (IL-6)
Time Frame: 2 hours post-ingestion
|
Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.
|
2 hours post-ingestion
|
|
Serum C-reactive protein (CRP)
Time Frame: baseline
|
Serum levels of CRP will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.
|
baseline
|
|
Serum C-reactive protein (CRP)
Time Frame: 2 hours post-ingestion
|
Serum levels of CRP will be analyzed using enzyme-linked immunosorbent assay (ELISA) as an indication of systemic inflammation.
|
2 hours post-ingestion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recognition memory on RAVLT
Time Frame: baseline
|
In the final task of the Rey Auditory Verbal Learning Test, participants need to recognize the 15 words from List A from a list of 50 words.
Recognition memory is defined as the number of correctly recognized words out of the total number of words.
|
baseline
|
|
Recognition memory on RAVLT
Time Frame: 2 hours post-ingestion
|
In the final task of the Rey Auditory Verbal Learning Test, participants need to recognize the 15 words from List A from a list of 50 words.
Recognition memory is defined as the number of correctly recognized words out of the total number of words.
|
2 hours post-ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2021
Primary Completion (Actual)
August 27, 2021
Study Completion (Actual)
August 27, 2021
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
June 9, 2021
First Posted (Actual)
June 22, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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