NCT05717452

Brief Summary

This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

January 28, 2023

Last Update Submit

February 9, 2023

Conditions

MoodAffectExecutive Function

Keywords

BlueberryAnthocyanins

Outcome Measures

Primary Outcomes (1)

  • 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.

    1.5 hours post-ingestion

Secondary Outcomes (3)

  • Negative affect as measured by PANAS-X

    1.5 hours post-ingestion

  • Executive function (accuracy)

    1.5 hours post-ingestion

  • Reaction time

    1.5 hours post-ingestion

Study Arms (2)

Blueberry drink

EXPERIMENTAL
Dietary Supplement: Blueberry drink

Placebo drink

PLACEBO COMPARATOR
Dietary Supplement: Placebo drink

Interventions

Blueberry drinkDIETARY_SUPPLEMENT

22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water.

Blueberry drink
Placebo drinkDIETARY_SUPPLEMENT

22 g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water.

Placebo drink

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 25 years of age

You may not qualify if:

  • Any medically significant condition or mental health disorder (e.g. diabetes, endocrine or gastrointestinal disorders)
  • Taking medication (excluding hormonal contraception or medication for asthma/seasonal allergies)
  • Allergy to blueberries or any other Vaccinium species

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

RECRUITING

Central Study Contacts

Claire Williams, Professor

CONTACT

+441183787540claire.williams@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Standard two-arm trial with a placebo arm and active intervention arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Claire Williams

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

GB(1)