- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721468
Trout Consumption in Young Children and Families and Brain Health
December 3, 2024 updated by: University of Idaho
Increasing Trout Consumption in Young Children and Families for Cognitive and Mental Health Benefit
Regular fish consumption may support brain health.
Trout lines developed in Idaho contain higher levels of omega-3 fatty acids, nutrients important for human cognition and mental wellbeing.
Developed to support aquaculture sustainability, consumer preferences and human health benefits of these fish are unknown.
The long-term goal of this project is to utilize nutrition education strategies to increase adult and child consumption of fish to improve brain health as measured by cognitive and emotional wellbeing.
Research objectives and activities include, (1) adult and child consumer panels to provide sensory evaluation on three strains of trout, (2) effects of repeated exposure (RE) and child-centered nutrition phrases (CCNP) on eating behaviors and brain health will be determined using one control and two treatment groups of children in childcare settings, (3) effects of nutrition education, incorporating CCNP and fish preparation techniques, and RE targeting family meals on eating behaviors of children and brain health of adults and children will be determined using four treatment groups in the home setting.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Regular fish consumption may support brain health.
Trout lines developed in Idaho contain higher levels of omega-3 fatty acids, nutrients important for human cognition and mental wellbeing.
Developed to support aquaculture sustainability, consumer preferences and human health benefits of these fish are unknown.
The long-term goal of this integrated project is to utilize nutrition education strategies to increase adult and child consumption of fish to improve brain health as measured by cognitive and emotional wellbeing.
The long-term impact of this project addresses the key knowledge gap in understanding strategies to increase fish consumption in children and adults, which has the positive implication to improve adult and child cognitive and emotional wellbeing.
As knowledge of the health benefits of foods such as fish, may not result in increased consumption, this study can provide evidence of repeated exposure and applied educational tools to facilitate consumption by children and adults.
Results from this study will fill the gap to provide greater knowledge of cognitive and emotional wellbeing health benefits of fish consumption and strategies for increasing adult and children's fish consumption.
A greater intake of fish not only has the potential to contribute to improved population health outcomes, but also has a probable role in sustainability of US agriculture and food systems through promotion of this cost effective source of protein.
In addition, better understanding the sensory perceptions of consumers in relation to fish with varied diets is an important step in identifying additional strategies to grow the aquaculture industry.
The specific lines of trout being developed at the Hagerman facility do have a focus on sustainability through feeding plant-based diets rather than the traditional fish meal diet, which is less sustainable and more taxing on the aquaculture industry.
Having the data on consumer acceptance, and evidence to support nutrition education strategies to increase liking, and consumption of these lines of trout will contribute to the overall sustainability goals.
Study Type
Interventional
Enrollment (Estimated)
99
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 Contact
- Name: Annie J Roe, PhD
- Phone Number: 208-885-1709
- Email: aroe@uidaho.edu
Study Contact Backup
- Name: Matt Powell, PhD
- Phone Number: 208-837-9096
- Email: mpowell@uidaho.edu
Study Locations
-
-
Idaho
-
Moscow, Idaho, United States, 83843
- Recruiting
- University of Idaho
-
Contact:
- Annie Roe, PhD
- Phone Number: 208-885-1709
- Email: aroe@uidaho.edu
-
Contact:
- Jenna Gardiner, BS
- Email: jgardiner@uidaho.edu
-
-
Washington
-
Pullman, Washington, United States, 99164
- Recruiting
- Washington State University
-
Contact:
- Carolyn Ross, PhD
- Email: cfross@wsu.edu
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Objective 1: Children 3-6 years of age, adults age 18+, English speaking
- Objective 2: Children 4-6 years of age, English speaking
- Objective 3: Children 4-9 years of age AND parent/guardian, English or Spanish speaking, access to internet, currently eat fish less than twice per week
Exclusion Criteria:
- allergy or dietary restriction preventing consuming fish
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Objective 1: Sensory Evaluation
three different strains of trout (fish-meal diet, CX line, CLX line)
|
rainbow trout
|
|
Experimental: Objective 2: Repeated Exposure
2 oz of trout each week for 10 weeks
|
rainbow trout
|
|
Experimental: Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases
2 oz of trout each week plus exposure to positive nutrition message about trout each week for 10 weeks
|
rainbow trout
learn the phrase, "trout helps your brain so you can learn and play" either through researcher introduction or completing the "About Trout!
Pond to Plate" curriculum
|
|
Placebo Comparator: Objective 2: Puzzle Game
Exposure to a puzzle game each week for 10 weeks
|
presented with a puzzle to solve each week
|
|
No Intervention: Objective 3: Eat Smart Idaho
Only receive Eat Smart Idaho's standard 6-lesson in-person series of classes
|
|
|
Experimental: Objective 3: Child-Centered Nutrition Phrases
Receive Eat Smart Idaho's standard 6-lesson in-person series of classes AND asked to view an online trout-specific nutrition education and recipe preparation video series, "About Trout!
Pond to Plate."
|
learn the phrase, "trout helps your brain so you can learn and play" either through researcher introduction or completing the "About Trout!
Pond to Plate" curriculum
|
|
Experimental: Objective 3: Repeated Exposure
Receive Eat Smart Idaho's standard 6-lesson in-person series of classes AND receive 2 servings of trout per week for 12 weeks, to prepare at home and consume (2 oz.
serving for child and 4 oz.
serving for adult).
|
rainbow trout
|
|
Experimental: Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases
Receive Eat Smart Idaho's standard 6-lesson in-person series of classes, AND receive 2 servings of trout per week for 12 weeks, to prepare at home and consume (2 oz.
serving for child and 4 oz.
serving for adult), AND asked to view an online trout-specific nutrition education and recipe preparation video series, "About Trout!
Pond to Plate."
|
rainbow trout
learn the phrase, "trout helps your brain so you can learn and play" either through researcher introduction or completing the "About Trout!
Pond to Plate" curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in liking from baseline to 12-weeks
Time Frame: Change from baseline liking at 12-weeks
|
subjects rate their liking of trout on a 3-point scale (yummy, just okay, yucky)
|
Change from baseline liking at 12-weeks
|
|
Change in intake from baseline to 12-weeks
Time Frame: Change from baseline intake at 12-weeks
|
Subjects are offered 2oz of trout each week for 12 weeks.
Trout servings are weighed pre/post consumption as a proxy of intake.
|
Change from baseline intake at 12-weeks
|
|
Change in cognition composite score from baseline to 12-weeks
Time Frame: Change from baseline cognition composite score at 12-weeks
|
Subjects complete a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application.
Early childhood cognition composite score is derived from scores on tthe Dimensional Change Card Sort, Flanker, Picture Sequence Memory, Picture Vocabulary, and Speeded Matching tests.
|
Change from baseline cognition composite score at 12-weeks
|
|
Change in emotion score from baseline to 12-weeks
Time Frame: Change from baseline emotion score at 12-weeks
|
Subjects complete a battery of computerized self-reported or parent proxy questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function.
|
Change from baseline emotion score at 12-weeks
|
|
Difference in liking among three trout strains
Time Frame: measured 1 time upon enrollment
|
subjects rate their liking of three different trout strains
|
measured 1 time upon enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fluid cognition composite score from baseline to 12-weeks
Time Frame: Change from baseline cognition composite score at 12-weeks
|
Subjects complete a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application.
Fluid cognition composite score is derived from scores on the dimensional change card sort, flanker, picture sequence memory, list sorting, and pattern comparison tests.
|
Change from baseline cognition composite score at 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Annie J Roe, PhD, University of Idaho
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)
May 13, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
December 3, 2024
First Submitted That Met QC Criteria
December 3, 2024
First Posted (Estimated)
December 6, 2024
Study Record Updates
Last Update Posted (Estimated)
December 6, 2024
Last Update Submitted That Met QC Criteria
December 3, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 23-033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Persons requesting the data will be required to obtain and share IRB approval and to sign a data sharing agreement.
Data will be made available one year after the primary manuscripts detailing the major outcomes of the study are published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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