Clinical trial NCT04647019: The Effects of Wild Blueberries on Depressive Symptoms in Young Adults
Official title: The Effects of Wild Blueberries on Depressive Symptoms in Young Adults: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Anhedonia
Keywords: Blueberry
Anthocyanins
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Wild Blueberry Association of North America
First posted: 2020-11-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 weeks
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: 6 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS) - modified version
timeFrame: 6 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: 6 weeks
measure: Composite Quality of Life Index
timeFrame: 6 weeks
measure: Positive affect as measured by PANAS-X
timeFrame: 2 hours post-ingestion
measure: Positive affect as measured by PANAS-X
timeFrame: 6 weeks
measure: Negative affect as measured by PANAS-X
timeFrame: 2 hours post-ingestion
measure: Negative affect as measured by PANAS-X
timeFrame: 6 weeks
measure: Cognitive flexibility
timeFrame: 2 hours post-ingestion
measure: Cognitive flexibility
timeFrame: 6 weeks
measure: Brain-derived neutrophic factor (BDNF) in serum
timeFrame: 6 weeks
measure: Interleukin-6 (IL-6) in serum
timeFrame: 6 weeks
measure: C-reactive protein (CRP) in serum
timeFrame: 6 weeks
measure: Uric acid in serum
timeFrame: 6 weeks
measure: Serum total antioxidant capacity (TAC)
timeFrame: 6 weeks
measure: Serum superoxide dismutase (SOD)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: School of Psychology and Clinical Languages, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Claire Williams, Professor
role: PRINCIPAL_INVESTIGATOR
References: