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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05717452
Other study ID # 2022-140-RC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date April 30, 2023

Study information

Verified date February 2023
Source University of Reading
Contact Claire Williams, Professor
Phone +441183787540
Email claire.williams@reading.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, single-blind, placebo-controlled design. A total of 80 participants will be randomly allocated to consume either a drink prepared with 22 g blueberry powder or a drink prepared with 22 g placebo powder matched for macronutrients, flavour and colour.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 18 to 25 years of age Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Blueberry drink
22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water.
Placebo drink
22 g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water.

Locations

Country Name City State
United Kingdom School of Psychology and Clinical Languages, University of Reading Reading Berkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Reading Wild Blueberry Association of North America (WBANA)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 1.5 hours post-ingestion
Secondary Executive function (accuracy) 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%). 1.5 hours post-ingestion
Secondary Reaction time The average reaction time on correct trials of the task-switching test (in milliseconds). 1.5 hours post-ingestion
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