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RecruitingNCT06721468Updated Dec 6, 2024

Trout Consumption in Young Children and Families and Brain Health

An interventional study of Trout and Child-centered nutrition phrases in Cognitive Change and Well-Being, Psychological, sponsored by University of Idaho. Recruiting at 2 sites in United States. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Idaho · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cognitive Change
  • Well-Being, Psychological

Keywords

  • Trout
  • Children
  • Child-Centered Nutrition Phrases
  • Cognition
  • Emotional well-being
  • Sensory evaluation
03

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • allergy or dietary restriction preventing consuming fish
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (estimated)

Study arms

  • Experimental
    Objective 1: Sensory Evaluation

    three different strains of trout (fish-meal diet, CX line, CLX line)

    Other: Trout

  • Experimental
    Objective 2: Repeated Exposure

    2 oz of trout each week for 10 weeks

    Other: 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

    Other: Trout · Other: Child-centered nutrition phrases

  • Placebo comparator
    Objective 2: Puzzle Game

    Exposure to a puzzle game each week for 10 weeks

    Other: Puzzle

  • 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."

    Other: Child-centered nutrition phrases

  • 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).

    Other: 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."

    Other: Trout · Other: Child-centered nutrition phrases

Interventions

  • OtherTrout

    rainbow trout

  • OtherChild-centered nutrition phrases

    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

  • OtherPuzzle

    presented with a puzzle to solve each week

05

What researchers measure

Primary outcomes

  1. Change in liking from baseline to 12-weeks

    subjects rate their liking of trout on a 3-point scale (yummy, just okay, yucky)

    Time frame: Change from baseline liking at 12-weeks

  2. 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.

    Time frame: Change from baseline intake at 12-weeks

  3. 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.

    Time frame: Change from baseline cognition composite score at 12-weeks

  4. 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.

    Time frame: Change from baseline emotion score at 12-weeks

  5. Difference in liking among three trout strains

    subjects rate their liking of three different trout strains

    Time frame: 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.

    Time frame: Change from baseline cognition composite score at 12-weeks

06

Study locations

2 of 2 sites recruiting
  • University of Idaho
    Moscow, Idaho 83843, United States
    Recruiting
  • Washington State University
    Pullman, Washington 99164, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06721468
Lead sponsor
University of Idaho
Collaborators
Washington State University
Responsible party
Sponsor
First posted
Dec 6, 2024
Start date
May 13, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Dec 6, 2024

Study contacts

Annie J Roe, PhD
Contact
aroe@uidaho.edu
208-885-1709
Matt Powell, PhD
Contact
mpowell@uidaho.edu
208-837-9096
Annie J Roe, PhD
principal investigator · University of Idaho

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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