An interventional study of Wild blueberry powder and Placebo powder in Depression, Anxiety and Anhedonia, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by University of Reading · Not applicable, Interventional, and Treatment
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.
119 studies on the registry are indexed under Anhedonia; 44 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 99 interventional studies indexed under Anhedonia.
Browse Anhedonia studies →University of Reading is the lead sponsor of 146 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Wild blueberry powder
Dietary Supplement: Placebo powder
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.
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.
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%).
Time frame: 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%).
Time frame: 6 weeks
Brain-derived neutrophic factor (BDNF) in serum
Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Uric acid in serum
Serum levels of uric acid will be measured using an automated chemistry analyzer.
Time frame: 6 weeks
Serum total antioxidant capacity (TAC)
The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status.
Time frame: 6 weeks
Serum superoxide dismutase (SOD)
Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress.
Time frame: 6 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University of Reading