Cognitive ChangeNCT06721468
Trout Consumption in Young Children and Families and Brain Health
A study testing Trout, Child-centered nutrition phrases and Puzzle in people with Cognitive Change and Well-Being, Psychological, run by University of Idaho at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Well-Being, Psychological
- What is being tested?
- Trout, Child-centered nutrition phrases and Puzzle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergy or dietary restriction preventing consuming fish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Idaho
Moscow, Idaho, 83843
Annie Roe, PhD, 208-885-1709, aroe@uidaho.edu
Jenna Gardiner, BS, jgardiner@uidaho.edu
- Recruiting
Washington State University
Pullman, Washington, 99164
Carolyn Ross, PhD, cfross@wsu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Change, Well-Being, Psychological
- Being tested
- Trout, Child-centered nutrition phrases, Puzzle
- Keywords
- Trout, Children, Child-Centered Nutrition Phrases, Cognition, Emotional well-being, Sensory evaluation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroutOther
rainbow trout
Child-centered nutrition phrasesOther
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
PuzzleOther
presented with a puzzle to solve each week
| Study group | Role | What they receive |
|---|---|---|
| Objective 1: Sensory Evaluation | Experimental | three different strains of trout (fish-meal diet, CX line, CLX line) Receives: Other: Trout |
| Objective 2: Repeated Exposure | Experimental | 2 oz of trout each week for 10 weeks Receives: Other: Trout |
| Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases | Experimental | 2 oz of trout each week plus exposure to positive nutrition message about trout each week for 10 weeks Receives: Other: Trout; Other: Child-centered nutrition phrases |
| Objective 2: Puzzle Game | Placebo comparator | Exposure to a puzzle game each week for 10 weeks Receives: Other: Puzzle |
| Objective 3: Eat Smart Idaho | No intervention | Only receive Eat Smart Idaho's standard 6-lesson in-person series of classes |
| Objective 3: Child-Centered Nutrition Phrases | Experimental | 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." Receives: Other: Child-centered nutrition phrases |
| Objective 3: Repeated Exposure | Experimental | 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). Receives: Other: Trout |
| Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases | Experimental | 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." Receives: Other: Trout; Other: Child-centered nutrition phrases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liking from baseline to 12-weeks
subjects rate their liking of trout on a 3-point scale (yummy, just okay, yucky)
Measured: Change from baseline liking at 12-weeks
Change in intake from baseline to 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.
Measured: Change from baseline intake at 12-weeks
Change in cognition composite score from baseline to 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.
Measured: Change from baseline cognition composite score at 12-weeks
Change in emotion score from baseline to 12-weeks
Subjects complete a battery of computerized self-reported or parent proxy questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function.
Measured: Change from baseline emotion score at 12-weeks
Difference in liking among three trout strains
subjects rate their liking of three different trout strains
Measured: measured 1 time upon enrollment
Secondary outcomes (1)
Change in fluid cognition composite score from baseline to 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.
Measured: Change from baseline cognition composite score at 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start13 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Objective 1: Two untrained consumer panels will provide sensory evaluation on three different strains of trout (fish-meal diet, CX line, CLX line). Objective 2: A within subjects, pre/post design will be employed to compare the effect of repeated exposure (RE) and repeated exposure plus child centered nutrition phrases (RE+CCNP) on eating behaviors of children 4-6 years of age. Objective 3: A 12-week quasi-experimental design will be employed to capture the translational impact of repeated exposure and nutrition education to the home setting on intake of whole CX line trout and the effect on adult and youth cognitive and emotional wellbeing outcomes. A control and three treatment groups will be recruited from a convenience sample of Eat Smart Idaho participants in northern and south central Idaho.
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University
- Responsible party
- Sponsor
- Investigators
- Annie J Roe, PhD, Principal investigator, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721468
- Sponsor's protocol ID
- 23-033
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Trout Consumption in Young Children and Families for Cognitive and Mental Health Benefit
- ClinicalTrials.gov ID
- NCT06721468
- Acronym / sponsor ID
- 23-033
- Conditions
- Cognitive Change, Well-Being, Psychological
- Keywords
- Trout, Children, Child-Centered Nutrition Phrases, Cognition, Emotional well-being, Sensory evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- Washington State University
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Objective 1: Two untrained consumer panels will provide sensory evaluation on three different strains of trout (fish-meal diet, CX line, CLX line). Objective 2: A within subjects, pre/post design will be employed to compare the effect of repeated exposure (RE) and repeated exposure plus child centered nutrition phrases (RE+CCNP) on eating behaviors of children 4-6 years of age. Objective 3: A 12-week quasi-experimental design will be employed to capture the translational impact of repeated exposure and nutrition education to the home setting on intake of whole CX line trout and the effect on adult and youth cognitive and emotional wellbeing outcomes. A control and three treatment groups will be recruited from a convenience sample of Eat Smart Idaho participants in northern and south central Idaho.
| Arm | Type | Receives |
|---|---|---|
| Objective 1: Sensory Evaluation | Experimental | Other: Troutthree different strains of trout (fish-meal diet, CX line, CLX line) |
| Objective 2: Repeated Exposure | Experimental | Other: Trout2 oz of trout each week for 10 weeks |
| Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases | Experimental | Other: Trout, Other: Child-centered nutrition phrases2 oz of trout each week plus exposure to positive nutrition message about trout each week for 10 weeks |
| Objective 2: Puzzle Game | Placebo comparator | Other: PuzzleExposure to a puzzle game each week for 10 weeks |
| Objective 3: Eat Smart Idaho | No intervention | –Only receive Eat Smart Idaho's standard 6-lesson in-person series of classes |
| Objective 3: Child-Centered Nutrition Phrases | Experimental | Other: Child-centered nutrition phrasesReceive 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." |
| Objective 3: Repeated Exposure | Experimental | Other: TroutReceive 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). |
| Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases | Experimental | Other: Trout, Other: Child-centered nutrition phrasesReceive 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." |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- allergy or dietary restriction preventing consuming fish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Troutrainbow trout | Other | Objective 1: Sensory Evaluation, Objective 2: Repeated Exposure, Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases, Objective 3: Repeated Exposure, Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases |
| Child-centered nutrition phraseslearn 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 | Other | Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases, Objective 3: Child-Centered Nutrition Phrases, Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases |
| Puzzlepresented with a puzzle to solve each week | Other | Objective 2: Puzzle Game |
Primary outcome
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 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 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 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.
Difference in liking among three trout strains
Time frame: measured 1 time upon enrollment
subjects rate their liking of three different trout strains
1 secondary outcome
Change in fluid cognition composite score from baseline to 12-weeks
Time frame: Change from baseline cognition composite score at 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annie J Roe, PhD principal investigator
University of Idaho
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trout, Child-centered nutrition phrases and Puzzle in people with Cognitive Change and Well-Being, Psychological, run by University of Idaho at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie J Roe, PhD (208-885-1709, aroe@uidaho.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liking from baseline to 12-weeks (time frame: Change from baseline liking at 12-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.