- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05717452
Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults
February 9, 2023 updated by: Prof Claire Williams, University of Reading
Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults: a Single-Blind, Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6AL
- Recruiting
- School of Psychology and Clinical Languages, University of Reading
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo drink
|
22 g placebo powder matched for macronutrients, color, and flavor mixed with 250 ml water.
|
EXPERIMENTAL: Blueberry drink
|
22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder mixed with 250 ml water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive affect as measured by PANAS-X
Time Frame: 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.
|
1.5 hours post-ingestion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative affect as measured by PANAS-X
Time Frame: 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.
|
1.5 hours post-ingestion
|
Executive function (accuracy)
Time Frame: 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%).
|
1.5 hours post-ingestion
|
Reaction time
Time Frame: 1.5 hours post-ingestion
|
The average reaction time on correct trials of the task-switching test (in milliseconds).
|
1.5 hours post-ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2023
Primary Completion (ANTICIPATED)
April 30, 2023
Study Completion (ANTICIPATED)
April 30, 2023
Study Registration Dates
First Submitted
January 28, 2023
First Submitted That Met QC Criteria
January 28, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-140-RC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Executive Function
-
University School of Physical Education in WroclawActive, not recruitingCognitive Function | Executive FunctionPoland
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Recruiting
-
University of North Carolina, Chapel HillSigma XiCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedExecutive FunctionUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnited States Department of DefenseNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedExecutive FunctionUnited States
-
Rotman Research Institute at BaycrestUniversity of TorontoUnknown
-
University of Sao PauloSwiss Tropical & Public Health Institute; Grand Challenges Canada; Harvard University and other collaboratorsUnknown
-
National Taiwan University HospitalCompletedExecutive Function | NeurosciencesTaiwan
-
Tjhin WigunaDr Cipto Mangunkusumo General Hospital; Fakultas Kedokteran Universitas Indonesia and other collaboratorsCompleted
Clinical Trials on Blueberry drink
-
University of ReadingNot yet recruitingHealthy | Parents | Mood
-
University of UtahCompletedHyperglycemia | Hypertension | DyslipidemiaUnited States
-
Karolinska University HospitalCompleted
-
Purdue UniversityUnknownOsteoporosis, Postmenopausal | Bone Loss, Age-relatedUnited States
-
University of Mississippi Medical CenterU.S. Highbush Blueberry CouncilCompleted
-
Duke UniversityU.S. Highbush Blueberry CouncilCompletedSedentary Lifestyle | Blood Pressure | Overweight and Obesity | Arterial StiffnessUnited States
-
University of ReadingNaurex, Inc, an affiliate of Allergan plcCompletedCognitive DeclineUnited Kingdom
-
Atlantic Food and Horticulture Research CenterDalhousie University; U.S. Highbush Blueberry CouncilCompleted
-
Appalachian State UniversityNorth Carolina State University; SinnovaTekCompleted