DepressionBluMoodNCT04647019
The Effects of Wild Blueberries on Depressive Symptoms in Young Adults
A study testing Wild blueberry powder in people with Depression and Anxiety, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study aims to investigate the effects of a 6-week dietary intervention of 22 g freeze-dried whole wild blueberry powder. The outcomes include measures of depression, anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Depression, Anxiety, Anhedonia
- 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
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2021to 11 Jun 2022
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 24 years of age
- Patient Health Questionnaire-9 score ≥ 10 and a score ≥ 2 on the sum of items 1 and 2
- Willingness to provide blood samples
Who cannot join
- Any medically significant condition (e.g. diabetes, endocrine or gastrointestinal disorders)
- Taking medication (excluding hormonal contraception)
- History of mental illness (excluding anxiety and unipolar depressive disorders)
- Allergy to blueberries or any other Vaccinium species
- Receiving psychotherapy or counselling
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
About this study
Official title: The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial
This study aims to investigate the effects of a 6-week dietary intervention of 22 g freeze-dried whole wild blueberry powder. The outcomes include measures of depression, anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress.
Read the detailed description
A randomized, double-blind, placebo-controlled, parallel-design study assessing the effects of a 6-week intervention of wild blueberry powder in young adults with depressive symptoms. A total of 60 participants will be randomly assigned to either 22 g blueberry powder or a matched placebo powder consumed daily with water. The severity of depression, anxiety, anhedonia, perceived stress, and quality of life will be measured at baseline and 6 weeks later. In addition, we will assess changes in cognitive function and transient mood 2 hours after consuming a single dose of blueberries.
- Conditions
- Depression, Anxiety, Anhedonia
- Being tested
- Wild blueberry powder, Placebo powder
- Keywords
- Blueberry, Anthocyanins
- Medical subject headings
- Depression, Anxiety Disorders, Anhedonia
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 consumed daily with 250 ml water. The powder is sealed in sachets and stored at -24 °C, except when transported. Participants are asked to store the sachets in a freezer until consumption.
Placebo powderDietary supplement
22 g placebo powder matched for macronutrients, color, and flavor consumed daily with 250 ml water. The powder is sealed in sachets and participants are asked to store the sachets in a freezer until consumption.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry powder | Experimental | Not described Receives: Dietary Supplement: Wild blueberry powder |
| Placebo powder | Experimental | Not described Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II)
A validated 21-item self-rated scale for assessing depression severity. The scale ranges from 0 to 63 points with higher scores indicating more severe depressive symptomatology.
Measured: 6 weeks
Secondary outcomes (17)
Patient Health Questionnaire-9 (PHQ-9)
A self-rated scale of depressive symptoms. The scale ranges from 0 to 27 points with higher scores indicating more severe depression.
Measured: 6 weeks
Generalized Anxiety Disorder 7-item Scale (GAD-7)
A brief self-rated scale of generalized anxiety. The scale ranges from 0 to 21 points with higher scores indicating more severe anxiety.
Measured: 6 weeks
Snaith-Hamilton Pleasure Scale (SHAPS) - modified version
A 14-item self-rated scale for measuring anhedonia. Each item has been modified to have five possible responses, which are scored as follows: "strongly disagree" (4 points), "somewhat disagree" (3 points), "neither agree nor disagree" (2 points), "somewhat agree" (1 point), "strongly agree" (0 points). Thus, the scale will range from 0 to 56 points with higher scores indicating greater levels of anhedonia.
Measured: 6 weeks
Perceived Stress Scale (PSS-10)
A validated 10-item questionnaire to measure levels of perceived stress. The scale ranges from 0 to 40 points with higher scores indicating greater stress levels.
Measured: 6 weeks
Composite Quality of Life Index
A 44-item composite index of quality of life derived by adding 11 facets of the WHOQOL-100 Questionnaire (General Health and Life Satisfaction, Pain and Discomfort, Energy and Fatigue, Sleep and Rest, Positive Feelings, Cognitive Function, Self-esteem, Negative Feelings, Activities of Daily Living, Work Capacity, and Personal Relationships). The scale ranges from 0 to 176 points with higher scores indicating better quality of life.
Measured: 6 weeks
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: 2 hours post-ingestion
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: 6 weeks
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: 2 hours post-ingestion
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: 6 weeks
Cognitive flexibility
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: 2 hours post-ingestion
Cognitive flexibility
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: 6 weeks
Brain-derived neutrophic factor (BDNF) in serum
Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).
Measured: 6 weeks
Interleukin-6 (IL-6) in serum
Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as a marker of systemic inflammation.
Measured: 6 weeks
C-reactive protein (CRP) in serum
Serum levels of CRP will be measured using an automated chemistry analyzer as a marker of systemic inflammation.
Measured: 6 weeks
Uric acid in serum
Serum levels of uric acid will be measured using an automated chemistry analyzer.
Measured: 6 weeks
Serum total antioxidant capacity (TAC)
The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status.
Measured: 6 weeks
Serum superoxide dismutase (SOD)
Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start26 Nov 2021
- Primary completion11 Jun 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
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
- Investigators
- Claire Williams, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647019
- Sponsor's protocol ID
- 20/13
- Acronym
- BluMood
- Status last verified
- Jan 2023
- First submitted
- 21 Oct 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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.
Publications
Velichkov M, Bezur Z, van Reekum CM, Williams CM. A biphasic response to blueberry supplementation on depressive symptoms in emerging adults: a double-blind randomized controlled trial. Eur J Nutr. 2024 Jun;63(4):1071-1088. doi: 10.1007/s00394-023-03311-9. Epub 2024 Feb 1.
PubMed 38300292
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04647019
- Acronym / sponsor ID
- BluMood / 20/13
- Conditions
- Depression, Anxiety, Anhedonia
- Keywords
- Blueberry, Anthocyanins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Wild Blueberry Association of North America
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 30 Nov 2020 (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 the effects of a 6-week dietary intervention of 22 g freeze-dried whole wild blueberry powder. The outcomes include measures of depression, anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress.
Detailed description
A randomized, double-blind, placebo-controlled, parallel-design study assessing the effects of a 6-week intervention of wild blueberry powder in young adults with depressive symptoms. A total of 60 participants will be randomly assigned to either 22 g blueberry powder or a matched placebo powder consumed daily with water. The severity of depression, anxiety, anhedonia, perceived stress, and quality of life will be measured at baseline and 6 weeks later. In addition, we will assess changes in cognitive function and transient mood 2 hours after consuming a single dose of blueberries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry powder | Experimental | Dietary Supplement: Wild blueberry powder |
| Placebo powder | Experimental | Dietary Supplement: Placebo powder |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 24 years of age
- Patient Health Questionnaire-9 score ≥ 10 and a score ≥ 2 on the sum of items 1 and 2
- Willingness to provide blood samples
Key exclusion criteria (5 listed)
- Any medically significant condition (e.g. diabetes, endocrine or gastrointestinal disorders)
- Taking medication (excluding hormonal contraception)
- History of mental illness (excluding anxiety and unipolar depressive disorders)
- Allergy to blueberries or any other Vaccinium species
- Receiving psychotherapy or counselling
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 |
|---|---|---|
| Wild blueberry powder22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder consumed daily with 250 ml water. The powder is sealed in sachets and stored at -24 °C, except when transported. Participants are asked to store the sachets in a freezer until consumption. | Dietary supplement | Blueberry powder |
| Placebo powder22 g placebo powder matched for macronutrients, color, and flavor consumed daily with 250 ml water. The powder is sealed in sachets and participants are asked to store the sachets in a freezer until consumption. | Dietary supplement | Placebo powder |
Primary outcome
Beck Depression Inventory-II (BDI-II)
Time frame: 6 weeks
A validated 21-item self-rated scale for assessing depression severity. The scale ranges from 0 to 63 points with higher scores indicating more severe depressive symptomatology.
17 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 weeks
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: 6 weeks
Snaith-Hamilton Pleasure Scale (SHAPS) - modified version
Time frame: 6 weeks
Perceived Stress Scale (PSS-10)
Time frame: 6 weeks
Composite Quality of Life Index
Time frame: 6 weeks
Positive affect as measured by PANAS-X
Time frame: 2 hours post-ingestion
Positive affect as measured by PANAS-X
Time frame: 6 weeks
Negative affect as measured by PANAS-X
Time frame: 2 hours post-ingestion
Negative affect as measured by PANAS-X
Time frame: 6 weeks
Cognitive flexibility
Time frame: 2 hours post-ingestion
Cognitive flexibility
Time frame: 6 weeks
Brain-derived neutrophic factor (BDNF) in serum
Time frame: 6 weeks
Interleukin-6 (IL-6) in serum
Time frame: 6 weeks
C-reactive protein (CRP) in serum
Time frame: 6 weeks
Uric acid in serum
Time frame: 6 weeks
Serum total antioxidant capacity (TAC)
Time frame: 6 weeks
Serum superoxide dismutase (SOD)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 38300292Velichkov M, Bezur Z, van Reekum CM, Williams CM. A biphasic response to blueberry supplementation on depressive symptoms in emerging adults: a double-blind randomized controlled trial. Eur J Nutr. 2024 Jun;63(4):1071-1088. doi: 10.1007/s00394-023-03311-9. Epub 2024 Feb 1.
- 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.
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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.
Claire Williams, Professor principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wild blueberry powder in people with Depression and Anxiety, 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 3 inclusion and 5 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 31 Jan 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. 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?
Beck Depression Inventory-II (BDI-II) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647019, which also lists 1 linked publication.
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 31 Jan 2023.