MoodNCT05717452
Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults
A study testing Blueberry drink in people with Mood and Affect, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging 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, Executive Function
- What is being tested?
- Blueberry drink
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to 30 Apr 2023
- 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
Who cannot join
- Any medically significant condition or mental health disorder (e.g. diabetes, endocrine or gastrointestinal disorders)
- Taking medication (excluding hormonal contraception or medication for asthma/seasonal allergies)
- Allergy to blueberries or any other Vaccinium species
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
School of Psychology and Clinical Languages, University of Reading
Reading, Berkshire, RG6 6AL
Claire Williams, Professor, +441183787540, claire.williams@reading.ac.uk
Martin Velichkov, MSc
About this study
Official title: Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults: a Single-Blind, Randomized Controlled Trial
This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.
Read the detailed description
The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, single-blind, placebo-controlled design. A total of 80 participants will be randomly allocated to consume either a drink prepared with 22 g blueberry powder or a drink prepared with 22 g placebo powder matched for macronutrients, flavour and colour.
- Conditions
- Mood, Affect, Executive Function
- Being tested
- Blueberry drink, Placebo drink
- Keywords
- Blueberry, Anthocyanins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry drinkDietary supplement
22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water.
Placebo drinkDietary supplement
22 g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry drink | Experimental | Not described Receives: Dietary Supplement: Blueberry drink |
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive affect as measured by PANAS-X
Positive affect will be calculated by adding the values of the 21 positive items of the Positive and Negative Affect Schedule-X and the additional item "motivated". Thus, the scale will range from 0 to 88 points with higher scores indicating better mood.
Measured: 1.5 hours post-ingestion
Secondary outcomes (3)
Negative affect as measured by PANAS-X
Negative affect will be calculated by adding the values of the 25 negative items of the Positive and Negative Affect Schedule-X. Thus, the scale will range from 0 to 100 points with higher scores indicating worse mood.
Measured: 1.5 hours post-ingestion
Executive function (accuracy)
A task-switching test will be used to assess cognitive flexibility when switching between two predictable tasks requiring simple numerical decisions. The main outcome of interest is the average accuracy (0 to 100%).
Measured: 1.5 hours post-ingestion
Reaction time
The average reaction time on correct trials of the task-switching test (in milliseconds).
Measured: 1.5 hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard two-arm trial with a placebo arm and active intervention arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Wild Blueberry Association of North America
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717452
- Sponsor's protocol ID
- 2022-140-RC
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults: a Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05717452
- Acronym / sponsor ID
- 2022-140-RC
- Conditions
- Mood, Affect, Executive Function
- Keywords
- Blueberry, Anthocyanins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Wild Blueberry Association of North America
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.
Detailed description
The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, single-blind, placebo-controlled design. A total of 80 participants will be randomly allocated to consume either a drink prepared with 22 g blueberry powder or a drink prepared with 22 g placebo powder matched for macronutrients, flavour and colour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Standard two-arm trial with a placebo arm and active intervention arm
| Arm | Type | Receives |
|---|---|---|
| Blueberry drink | Experimental | Dietary Supplement: Blueberry drink |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 to 25 years of age
Key exclusion criteria (3 listed)
- Any medically significant condition or mental health disorder (e.g. diabetes, endocrine or gastrointestinal disorders)
- Taking medication (excluding hormonal contraception or medication for asthma/seasonal allergies)
- Allergy to blueberries or any other Vaccinium species
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry drink22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water. | Dietary supplement | Blueberry drink |
| Placebo drink22 g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water. | Dietary supplement | Placebo drink |
Primary outcome
Positive affect as measured by PANAS-X
Time frame: 1.5 hours post-ingestion
Positive affect will be calculated by adding the values of the 21 positive items of the Positive and Negative Affect Schedule-X and the additional item "motivated". Thus, the scale will range from 0 to 88 points with higher scores indicating better mood.
3 secondary outcomes
Negative affect as measured by PANAS-X
Time frame: 1.5 hours post-ingestion
Executive function (accuracy)
Time frame: 1.5 hours post-ingestion
Reaction time
Time frame: 1.5 hours post-ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry drink 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Williams, Professor (+441183787540, claire.williams@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive affect as measured by PANAS-X (time frame: 1.5 hours post-ingestion). 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 13 Feb 2023.