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| Name | Class |
|---|---|
| Wild Blueberry Association of North America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry powder | Experimental |
| |
| Placebo powder | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild blueberry powder | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Williams, Professor | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Psychology and Clinical Languages, University of Reading | Reading | Berkshire | RG6 6AL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38300292 | Derived | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2022 | Apr 20, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Placebo powder | Dietary 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. |
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A brief self-rated scale of generalized anxiety. The scale ranges from 0 to 21 points with higher scores indicating more severe anxiety.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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%). | 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%). | 6 weeks |
| Brain-derived neutrophic factor (BDNF) in serum | Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA). | 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. | 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. | 6 weeks |
| Uric acid in serum | Serum levels of uric acid will be measured using an automated chemistry analyzer. | 6 weeks |
| Serum total antioxidant capacity (TAC) | The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status. | 6 weeks |
| Serum superoxide dismutase (SOD) | Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress. | 6 weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |