Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults

• Sponsor: University of Reading (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05717452
• Collaborator: Wild Blueberry Association of North America (WBANA) (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.9
• Patients Per Site Per Month: 27.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mood; Affect; Executive Function	Dietary Supplement: Blueberry drink; Dietary Supplement: Placebo drink	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Standard two-arm trial with a placebo arm and active intervention armStandard two-arm trial with a placebo arm and active intervention arm
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults: a Single-Blind, Randomized Controlled Trial
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Positive affect as measured by PANAS-X [1.5 hours post-ingestion]

   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.

Secondary Outcome Measures

1. Negative affect as measured by PANAS-X [1.5 hours post-ingestion]

   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.

2. Executive function (accuracy) [1.5 hours post-ingestion]

   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%).

3. Reaction time [1.5 hours post-ingestion]

   The average reaction time on correct trials of the task-switching test (in milliseconds).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Psychology and Clinical Languages, University of Reading	Reading	Berkshire	United Kingdom	RG6 6AL

Sponsors and Collaborators

• University of Reading
• Wild Blueberry Association of North America (WBANA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2023

More Information

Publications

None provided.

• Responsible Party: Prof Claire Williams, Prof. Claire Williams, University of Reading
• ClinicalTrials.gov Identifier: NCT05717452
• Other Study ID Numbers: 2022-140-RC
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof Claire Williams, Prof. Claire Williams, University of Reading: Blueberry; Anthocyanins

Study Results

No Results Posted as of Feb 13, 2023