Walnuts as an Infant Solid Food for Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-5
SponsorColorado State University
About this trial
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.
Eligibility criteria
Qualifiers
Full term: gestational age ≥ 37 weeks
Generally healthy without conditions that would affect normal growth
No significant consumption of complementary food (e.g., no more than 1 oz of solid foods per week)
Exclusively breastfed (< 2 weeks of cumulative formula exposure)
Disqualifiers
Adults unable to consent
Pregnant women
Prisoners
Trial design
Treatments tested in this trial
- Infant walnut intake
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Colorado State University
Lead sponsor
California Walnut Commission
Collaborator
Source ClinicalTrials.gov