The Effects of Wild Blueberries on Depressive Symptoms in Young Adults

NCT ID: NCT04647019

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-26

Study Completion Date

2022-06-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Anxiety Anhedonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Blueberry powder

Group Type EXPERIMENTAL

Wild blueberry powder

Intervention Type 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.

Placebo powder

Group Type EXPERIMENTAL

Placebo powder

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wild Blueberry Association of North America

OTHER

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Prof Claire Williams

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Williams, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38300292 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20/13

Identifier Type: -

Identifier Source: org_study_id

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