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The Effects of Wild Blueberries on Depressive Symptoms in Young Adults (BluMood)

Primary Purpose

Depression, Anxiety, Anhedonia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Wild blueberry powder
Placebo powder
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Blueberry, Anthocyanins

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Psychology and Clinical Languages, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blueberry powder

Placebo powder

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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%).
Brain-derived neutrophic factor (BDNF) in serum
Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).
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.
C-reactive protein (CRP) in serum
Serum levels of CRP will be measured using an automated chemistry analyzer as a marker of systemic inflammation.
Uric acid in serum
Serum levels of uric acid will be measured using an automated chemistry analyzer.
Serum total antioxidant capacity (TAC)
The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status.
Serum superoxide dismutase (SOD)
Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress.

Full Information

First Posted
October 21, 2020
Last Updated
January 28, 2023
Sponsor
University of Reading
Collaborators
Wild Blueberry Association of North America (WBANA)
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1. Study Identification

Unique Protocol Identification Number
NCT04647019
Brief Title
The Effects of Wild Blueberries on Depressive Symptoms in Young Adults
Acronym
BluMood
Official Title
The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
June 11, 2022 (Actual)
Study Completion Date
June 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
Wild Blueberry Association of North America (WBANA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Anhedonia
Keywords
Blueberry, Anthocyanins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blueberry powder
Arm Type
Experimental
Arm Title
Placebo powder
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Wild blueberry powder
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II)
Description
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
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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
Title
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Description
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
Title
Snaith-Hamilton Pleasure Scale (SHAPS) - modified version
Description
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
Title
Perceived Stress Scale (PSS-10)
Description
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
Title
Composite Quality of Life Index
Description
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
Title
Positive affect as measured by PANAS-X
Description
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
Title
Positive affect as measured by PANAS-X
Description
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
Title
Negative affect as measured by PANAS-X
Description
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
Title
Negative affect as measured by PANAS-X
Description
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
Title
Cognitive flexibility
Description
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
Title
Cognitive flexibility
Description
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
Title
Brain-derived neutrophic factor (BDNF) in serum
Description
Serum levels of BDNF will be analyzed using enzyme-linked immunosorbent assay (ELISA).
Time Frame
6 weeks
Title
Interleukin-6 (IL-6) in serum
Description
Serum levels of IL-6 will be analyzed using enzyme-linked immunosorbent assay (ELISA) as a marker of systemic inflammation.
Time Frame
6 weeks
Title
C-reactive protein (CRP) in serum
Description
Serum levels of CRP will be measured using an automated chemistry analyzer as a marker of systemic inflammation.
Time Frame
6 weeks
Title
Uric acid in serum
Description
Serum levels of uric acid will be measured using an automated chemistry analyzer.
Time Frame
6 weeks
Title
Serum total antioxidant capacity (TAC)
Description
The total antioxidant capacity (TAC) of serum will be measured to assess systemic antioxidant status.
Time Frame
6 weeks
Title
Serum superoxide dismutase (SOD)
Description
Serum levels of superoxide dismutase (SOD) will be measured as an indicator of oxidative stress.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Williams, Professor
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Psychology and Clinical Languages, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

The Effects of Wild Blueberries on Depressive Symptoms in Young Adults

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