Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 5 months
Healthy Volunteers: f
View:

• 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)

Locations
United States
Colorado
Food Science and Human Nutrition Clinical Research Laboratory
RECRUITING
Fort Collins
Contact Information
Primary
Nathan Campbell, MS
Nathan.Campbell@colostate.edu
7655436716
Backup
Kinzie Matzeller, MS RDNCLC
kinzie.matzeller@colostate.edu
Time Frame
Start Date: 2025-05-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: California Walnut Commission
Leads: Colorado State University

This content was sourced from clinicaltrials.gov