Actively Recruiting
Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
Led by Colorado State University · Updated on 2025-07-23
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Colorado State University
Lead Sponsor
C
California Walnut Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of introducing walnuts as a first solid food on the gut bacteria, inflammation markers, atopic dermatitis, and allergy outcomes in breastfed infants during the early stages of complementary feeding. The study also aims to observe how walnut intake influences infant growth patterns and the risk of becoming overweight. Additionally, the research explores specific walnut-related food compounds linked to gut bacteria and immune system markers using advanced metabolomics techniques. Participants are divided into two groups: one group provides their infant with 10 grams of walnuts daily for 7 months, while the control group limits walnut and tree nut consumption. This randomized, double-blind study is led by Colorado State University and focuses on infants around 5 months of age during complementary feeding. Throughout the 7-month period, researchers will monitor changes in the infant's gut microbiome using specialized sequencing methods and measure growth in length and weight. They will also analyze dietary intake and track various inflammatory and immune markers such as interleukins and transforming growth factor beta. The study includes detailed assessments of walnut-specific compounds through metabolomics, helping to understand how walnuts influence immunity and gut health development in infants.
CONDITIONS
Brief Title
Walnuts as an Infant Solid Food for Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby was born full term (37 weeks or later)
- Baby is generally healthy without conditions affecting normal growth
- Baby has had little to no complementary solid foods (no more than about 1 ounce per week)
- Baby is exclusively breastfed with less than 2 weeks of cumulative formula exposure
You will not qualify if you...
- Adults unable to consent
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 months
Participants provide 10g of walnuts daily to their infant or limit walnut and tree nut intake to study the impact on gut microbiota and immunity during complementary feeding.
Regular visits during the 7-month intervention period to monitor infant growth and dietary intake
Trial Site Locations
Total: 1 location
1
Food Science and Human Nutrition Clinical Research Laboratory
Fort Collins, Colorado, United States, 80523
Actively Recruiting
Research Team
N
Nathan Campbell, MS
K
Kinzie Matzeller, MS RDNCLC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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