Walnuts as a first solid food for breastfed infants
Official title: Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
Run by Colorado State University · NCT07081698 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 5 Months to 5 Months |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Colorado State University Academic / other |
| Locations | 1 site (Fort Collins, Colorado) |
| Status | Recruiting |
| Started | May 18, 2025 |
| Main results expected | December 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT07081698 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Full-term, generally healthy breastfed infants with minimal prior solid-food or formula exposure are the intended participants.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.