Walnuts as an Infant Solid Food for Health

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT07081698
Status
Recruiting
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Conditions

  • Gut -Microbiota
  • Infant Development
  • Inflammatory Markers

Eligibility Criteria

Sex
ALL
Age
5 Months - 5 Months
Healthy Volunteers
Not accepted

Interventions

  • Infant walnut intake — OTHER
    The intervention group will receive walnuts at 10 g/day, and the control group will be advised to avoid walnuts/tree nuts during the intervention. The purpose of this research is to learn more about how walnuts as a first food in infants impact immunity and the development of bacteria living in your baby's gut.

Study Details

The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding. The three primary aims include: Aim 1: Evaluate the effect of walnut consumption on gut microbiota structure and function, inflammation, atopic dermatitis, and allergy outcomes. Aim 2: Evaluate the impact of walnut consumption on infant growth trajectories and risk of overweight. Aim 3 (exploratory): Identify walnut-specific food signatures that are associated with gut microbiota and immunity biomarkers using a novel nutri-metabolomics technique.

Key Dates

Start date
May 18, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: The walnut group
    The intervention group will provide 10g of walnuts daily to their infant for 7 months.
  • No Intervention: Control Group
    The control group will be asked to limit walnuts and tree nuts.

Primary Outcome Measure

Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing [ Time Frame: Over 7 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Food Science and Human Nutrition Clinical Research LaboratoryFort CollinsColorado80523
Nathan Campbell, M.S.
[email protected]
7655436716
Kinzie Matzeller, M.S., RDN, CLC
[email protected]
Minghua Tang, Phd. (PRINCIPAL_INVESTIGATOR)

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