NCT04647019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

October 21, 2020

Last Update Submit

January 28, 2023

Conditions

DepressionAnxietyAnhedonia

Keywords

BlueberryAnthocyanins

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Patient Health Questionnaire-9 (PHQ-9)

    6 weeks

  • Generalized Anxiety Disorder 7-item Scale (GAD-7)

    6 weeks

  • Snaith-Hamilton Pleasure Scale (SHAPS) - modified version

    6 weeks

  • Perceived Stress Scale (PSS-10)

    6 weeks

  • Composite Quality of Life Index

    6 weeks

  • +12 more secondary outcomes

Study Arms (2)

Blueberry powder

EXPERIMENTAL
Dietary Supplement: Wild blueberry powder

Placebo powder

EXPERIMENTAL
Dietary Supplement: Placebo powder

Interventions

Wild blueberry powderDIETARY_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.

Blueberry powder
Placebo powderDIETARY_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.

Placebo powder

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38300292DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersAnhedonia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claire Williams, Professor

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 30, 2020

Study Start

November 26, 2021

Primary Completion

June 11, 2022

Study Completion

June 11, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations

GB(1)