NCT07081698

Walnuts as an Infant Solid Food for Health

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 5 Months – 5 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Conditions

• Gut -Microbiota
• Inflammatory Markers
• Infant Development

Interventions

Type	Name	Description
OTHER	Infant walnut intake	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.

Timeline

• Start date: 2025-05-18
• Primary completion: 2027-12-01
• Completion: 2027-12-31
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States