The Effects of Wild Blueberries on Depressive Symptoms in Young Adults

Depression Clinical Trial

— BluMood  

Official title:

The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647019
• Other study ID #: 20/13
• Status: Completed
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: January 2023
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 11, 2022
• Est. primary completion date: June 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anhedonia
• Anxiety
• Depression

Intervention

Dietary Supplement:
• Wild blueberry 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.
• Placebo powder
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.

Locations

Country	Name	City	State
United Kingdom	School of Psychology and Clinical Languages, University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Wild Blueberry Association of North America (WBANA)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Brain-derived neutrophic factor (BDNF) in serum	Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).	6 weeks
Secondary	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
Secondary	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
Secondary	Uric acid in serum	Serum levels of uric acid will be measured using an automated chemistry analyzer.	6 weeks
Secondary	Serum total antioxidant capacity (TAC)	The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status.	6 weeks
Secondary	Serum superoxide dismutase (SOD)	Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress.	6 weeks