MoodBLUCAMPNCT06402916
The Acute Effects of Blueberries on Cognition and Mood in the Postpartum
A study testing Blueberry drink in people with Mood and Parents, run by University of Reading.
Trial summary
Blueberries are an excellent source of natural substances (flavonoids) with well-documented health benefits. Previous research has shown that consuming a serving of blueberries can improve mood in children, healthy young adults, and young adults with depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 1 Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be a biological mother or father to an infant aged 0-6 months.
- Have a good understanding of English language
Who cannot join
- Allergic to blueberries or any other Vaccinium species
- Participation in other interventional studies within the last month
- Participants with cancer, or conditions affecting the liver, heart or kidneys due to unknown effects on flavonoid metabolism
About this study
Blueberries are an excellent source of natural substances (flavonoids) with well-documented health benefits. Previous research has shown that consuming a serving of blueberries can improve mood in children, healthy young adults, and young adults with depressive symptoms. These results are consistent with a growing body of evidence from human and animal studies indicating that blueberries can have a beneficial effect on brain function and mental health. The postpartum period represents a challenging period whereby mood disorders such as postpartum depression become increasingly prevalent, in addition to this, mothers and fathers often report poorer cognition during this time. Therefore, it is of interest to explore whether acute blueberry supplementation can benefit mood and cognition for parents during this sensitive time.
The aim of the present study is to examine whether consuming a drink containing powdered blueberries can improve mood and cognition in parents in the 0-6 month postpartum. The design follows a randomised, double blind, placebo controlled cross over design. Participants will be invited to take part in an in-person study investigating a fruit drink on mood and cognition. Participants will come to the Nutrition-cognition lab at the Psychology department at the University of Reading for a screening session, after providing informed consent, participants will return a week later to attend a 3-hr visit during which they will receive either a blueberry or placebo drink and complete computer tasks and standardised questionnaires. Participants will then return a week later and complete the same procedure, consuming the other intervention drink.
Read the detailed description
The design follows a randomised, double blind, placebo controlled cross over design. Participants will be recruited via social media, posters in the local area, and through word of mouth and email advertisements and will be invited to take part in an in-person study investigating a fruit drink on mood and cognition. Participants will come to the Nutrition-cognition lab at the Psychology department for a screening session, during the session the study will be explained by the researcher and the participant will receive the participant information sheet. If the participant is eligible and wants to take part, they will sign the consent form. Data collected at screening will include age, ethnicity, highest level of education, marital status, specific diet, income, employment, physical illnesses, psychological diagnosis, regular medications, how old their infant is, infant gender, previous children, and age of other children as well as postnatal depression, postnatal anxiety (mother's sample only), state anxiety (father's sample only) a food frequency questionnaire and anthropometric measures to determine body mass index (BMI). Participants will then complete practice versions of the cognitive tests. Office for National Statistics recommendations will be used when collecting participants demographic details of ethnicity and income.
A week later, upon arrival at the Nutrition Cognition Lab (approximately 9am) participants will be asked to note what they had for breakfast (to ensure they have the same breakfast next week for standardisation) and a researcher will ask whether they have followed the pre-session restrictions prior to coming in for the visit (see below). Participants will then complete the mood and cognitive questionnaires (listed below) and have their blood pressure taken (duration 30 min). The order of questionnaires and cognitive tasks will be kept the same throughout the study. Participants will then be randomly allocated to consume one of two interventions (blueberry drink or a similarly flavoured placebo drink). The blueberry drink consists of 46g freeze dried wild blueberry powder mixed with 250ml water, the placebo drink contains 46g placebo powder matched for sugars and vitamin C content of the blueberry powder, mixed with 250ml water. The tests will then be repeated 2 hours after consuming the drink. Participants will be able to leave the lab and have free time for the 2hrs in between testing. During the procedure, we will also request that if participants bring their infant on the day, that they also bring a partner (friend, relative or parent of infant) to care for their infant during this time so to not distract the participant during the mood and cognitive tasks. Participants will then return to the lab a week later and carry out the same procedure, though consuming the other intervention drink. After the study has been completed, participants will be debriefed and given the opportunity to ask any questions. Participants will also be reminded of their right to withdraw their data from the study if they wish. Helplines and support web links will be provided to all participants as well as encouragement for participants to contact their GP should they wish to seek support. Helplines and weblinks include Samaritans UK and PANDAS Foundation. Weblinks to NHS, MIND and the Association for Postnatal Illness.
Pre-session restrictions: Twenty-four hours before the first and second test sessions, all participants will be advised to follow a low flavonoid diet which will be advised by an information sheet provided by the researchers upon sign-up. These restrictions will be implemented as a control measure so that other dietary flavonoids do not interfere with the results of the study and researchers will check adherence to restrictions prior to the first sitting of the study. Within this 24-hour period, participants will also be asked not to drink alcohol, caffeine or take recreational drugs. Participants will also be asked to refrain from exercise and food 2 hours before and following the intervention (water will be allowed) to avoid confounding effects.
- Being tested
- Blueberry drink, Placebo drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry drinkDietary supplement
Blueberry drink equivalent to 240g fresh blueberries.
Placebo drinkDietary supplement
Drink containing no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry drink | Experimental | 46g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water. Receives: Dietary Supplement: Blueberry drink |
| Placebo drink | Placebo comparator | 46g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water. Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean current affect
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
Measured: 2 hours post ingestion
Secondary outcomes (7)
Mean state anxiety
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4
Measured: 2 hours post ingestion
Mean subjective mood scores
Immediate mood scale-This questionnaire contains 22 items developed to assess dynamic components of mood. Participants are asked to rate their current mood state on a continuum using 7-point Likert scales (e.g., happy-sad, distracted-focused, sleepy-alert). For each item, an integer score between 1 and 7 is derived. The total score for this scale is the sum of the scores on all 22 items.
Measured: 2 hours post ingestion
Blood pressure
Resting systolic and diastolic blood pressure will be taken with an ambulatory blood pressure monitor. Measurements will be taken on participants left arm and the mean of three consecutive measurements will be calculated.
Measured: 2 hours post ingestion
Mean subjective feelings
These consists of 16 dimensions of mood: Slow-Quick Witted, Tense-Relaxed, Attentive-Dreamy, Incompetent-Proficient, Happy-Sad, Antagonistic-Friendly, Interested-Bored, Withdrawn-Social. The participant is required to mark, on a line to what extent the described state is appropriate to them at that moment in time. The individual responses from the 16 mood scales are combined to make three affective dimensions of alertness, contentment, and calmness.
Measured: 2 hours post ingestion
Verbal memory
Assessed using the Rey Auditory Verbal Learning Test.
Measured: 2 hours post ingestion
Sustained attention and executive functioning
Assessed with the Modified Attention Network Task with accuracy and reaction time as outcome measures.
Measured: 2 hours post ingestion
Visuospatial working memory
Measured using the Visuospatial n-back with accuracy and reaction time as outcome measures.
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.
- First posted7 May 2024
- Study start20 May 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lamport, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402916
- Sponsor's protocol ID
- UReading BLUCAMP
- Acronym
- BLUCAMP
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Blueberries on Cognition and Mood in the Postpartum
- ClinicalTrials.gov ID
- NCT06402916
- Acronym / sponsor ID
- BLUCAMP / UReading BLUCAMP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 May 2024 (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.
Blueberries are an excellent source of natural substances (flavonoids) with well-documented health benefits. Previous research has shown that consuming a serving of blueberries can improve mood in children, healthy young adults, and young adults with depressive symptoms. These results are consistent with a growing body of evidence from human and animal studies indicating that blueberries can have a beneficial effect on brain function and mental health. The postpartum period represents a challenging period whereby mood disorders such as postpartum depression become increasingly prevalent, in addition to this, mothers and fathers often report poorer cognition during this time. Therefore, it is of interest to explore whether acute blueberry supplementation can benefit mood and cognition for parents during this sensitive time.
The aim of the present study is to examine whether consuming a drink containing powdered blueberries can improve mood and cognition in parents in the 0-6 month postpartum. The design follows a randomised, double blind, placebo controlled cross over design. Participants will be invited to take part in an in-person study investigating a fruit drink on mood and cognition. Participants will come to the Nutrition-cognition lab at the Psychology department at the University of Reading for a screening session, after providing informed consent, participants will return a week later to attend a 3-hr visit during which they will receive either a blueberry or placebo drink and complete computer tasks and standardised questionnaires. Participants will then return a week later and complete the same procedure, consuming the other intervention drink.
Detailed description
The design follows a randomised, double blind, placebo controlled cross over design. Participants will be recruited via social media, posters in the local area, and through word of mouth and email advertisements and will be invited to take part in an in-person study investigating a fruit drink on mood and cognition. Participants will come to the Nutrition-cognition lab at the Psychology department for a screening session, during the session the study will be explained by the researcher and the participant will receive the participant information sheet. If the participant is eligible and wants to take part, they will sign the consent form. Data collected at screening will include age, ethnicity, highest level of education, marital status, specific diet, income, employment, physical illnesses, psychological diagnosis, regular medications, how old their infant is, infant gender, previous children, and age of other children as well as postnatal depression, postnatal anxiety (mother's sample only), state anxiety (father's sample only) a food frequency questionnaire and anthropometric measures to determine body mass index (BMI). Participants will then complete practice versions of the cognitive tests. Office for National Statistics recommendations will be used when collecting participants demographic details of ethnicity and income.
A week later, upon arrival at the Nutrition Cognition Lab (approximately 9am) participants will be asked to note what they had for breakfast (to ensure they have the same breakfast next week for standardisation) and a researcher will ask whether they have followed the pre-session restrictions prior to coming in for the visit (see below). Participants will then complete the mood and cognitive questionnaires (listed below) and have their blood pressure taken (duration 30 min). The order of questionnaires and cognitive tasks will be kept the same throughout the study. Participants will then be randomly allocated to consume one of two interventions (blueberry drink or a similarly flavoured placebo drink). The blueberry drink consists of 46g freeze dried wild blueberry powder mixed with 250ml water, the placebo drink contains 46g placebo powder matched for sugars and vitamin C content of the blueberry powder, mixed with 250ml water. The tests will then be repeated 2 hours after consuming the drink. Participants will be able to leave the lab and have free time for the 2hrs in between testing. During the procedure, we will also request that if participants bring their infant on the day, that they also bring a partner (friend, relative or parent of infant) to care for their infant during this time so to not distract the participant during the mood and cognitive tasks. Participants will then return to the lab a week later and carry out the same procedure, though consuming the other intervention drink. After the study has been completed, participants will be debriefed and given the opportunity to ask any questions. Participants will also be reminded of their right to withdraw their data from the study if they wish. Helplines and support web links will be provided to all participants as well as encouragement for participants to contact their GP should they wish to seek support. Helplines and weblinks include Samaritans UK and PANDAS Foundation. Weblinks to NHS, MIND and the Association for Postnatal Illness.
Pre-session restrictions: Twenty-four hours before the first and second test sessions, all participants will be advised to follow a low flavonoid diet which will be advised by an information sheet provided by the researchers upon sign-up. These restrictions will be implemented as a control measure so that other dietary flavonoids do not interfere with the results of the study and researchers will check adherence to restrictions prior to the first sitting of the study. Within this 24-hour period, participants will also be asked not to drink alcohol, caffeine or take recreational drugs. Participants will also be asked to refrain from exercise and food 2 hours before and following the intervention (water will be allowed) to avoid confounding effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry drink | Experimental | Dietary Supplement: Blueberry drink46g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water. |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink46g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be a biological mother or father to an infant aged 0-6 months.
- Have a good understanding of English language
Key exclusion criteria (3 listed)
- Allergic to blueberries or any other Vaccinium species
- Participation in other interventional studies within the last month
- Participants with cancer, or conditions affecting the liver, heart or kidneys due to unknown effects on flavonoid metabolism
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 drinkBlueberry drink equivalent to 240g fresh blueberries. | Dietary supplement | Blueberry drink |
| Placebo drinkDrink containing no active ingredient. | Dietary supplement | Placebo drink |
Primary outcome
Mean current affect
Time frame: 2 hours post ingestion
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
7 secondary outcomes
Mean state anxiety
Time frame: 2 hours post ingestion
Mean subjective mood scores
Time frame: 2 hours post ingestion
Blood pressure
Time frame: 2 hours post ingestion
Mean subjective feelings
Time frame: 2 hours post ingestion
Verbal memory
Time frame: 2 hours post ingestion
Sustained attention and executive functioning
Time frame: 2 hours post ingestion
Visuospatial working memory
Time frame: 2 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 7 May 2024.
- Individual participant dataSharing planned: Yes. Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
Related trials for Mood
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry drink in people with Mood and Parents, run by University of Reading.
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 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mean current affect (time frame: 2 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 7 May 2024.