Walnuts as a first solid food for breastfed infants
Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
This trial will test whether introducing small amounts of walnuts during early complementary feeding changes the gut microbiome, inflammation, eczema, and growth in healthy breastfed infants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 5 Months to 5 Months |
| Sex | All |
| Sponsor | Colorado State University Academic / other |
| Locations | 1 site (Fort Collins, Colorado) |
| Trial ID | NCT07081698 on ClinicalTrials.gov |
What this trial studies
Researchers will give controlled amounts of walnut to full-term, predominantly breastfed infants starting early in complementary feeding and follow changes in gut microbiota, inflammatory markers, atopic dermatitis status, allergy indices, and growth over time. The main aims are to track microbiome structure and function, inflammation and allergy-related outcomes, and growth trajectories, while an exploratory nutri-metabolomics analysis will look for walnut-specific food signatures linked to immunity markers. Eligible infants are generally healthy, born at term, and have minimal prior solid-food or formula exposure. The study is conducted at a clinical nutrition laboratory in Fort Collins, Colorado, and some procedural details are withheld until study completion.
Who should consider this trial
Good fit: Full-term, generally healthy breastfed infants with minimal prior solid-food or formula exposure are the intended participants.
Not a fit: Infants who were born preterm, have health conditions affecting normal growth, have significant prior formula or solid-food intake, or already regularly consume nuts are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, introducing walnuts early could reduce allergy or eczema risk and favorably shape the infant gut microbiome and growth patterns.
How similar studies have performed: Early introduction of peanut has shown allergy-prevention benefits, but trials specifically testing walnuts and their effects on the infant microbiome and inflammation are limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Adults unable to consent * Pregnant women * Prisoners
Where this trial is running
Fort Collins, Colorado
- Food Science and Human Nutrition Clinical Research Laboratory — Fort Collins, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Minghua Tang, Phd — Colorado State University
- Study coordinator: Nathan Campbell, MS
- Email: Nathan.Campbell@colostate.edu
- Phone: 7655436716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.