Walnuts as an Infant Solid Food for Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infant walnut intake.
- Who it may be relevant to
- Registry conditions: Gut -Microbiota, Inflammatory Markers, Infant Development. Basic parameters: 5 months — 5 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
Overview
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.
Interventions
- 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.
Primary outcome measures
- Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing [Time frame: Over 7 months]
- Infant Growth (Length) [Time frame: Over 7 months]
- Infant Growth (Weight) [Time frame: Over 7 months]
- Dietary Intake [Time frame: Over 7 months]
- IL-33 (Interleukin-33) [Time frame: Over 7 months]
- IL-6 (Interleukin-6) [Time frame: Over 7 months]
- IL-8 (Interleukin-8) [Time frame: Over 7 months]
- IL-13 (Interleukin-13) [Time frame: Over 7 months]
- TGF-b (Transforming growth factor beta) [Time frame: Over 7 months]
- IL-4 (Interleukin-4) [Time frame: Over 7 months]
Secondary outcome measures (1)
- Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis [Time frame: Over 7 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Food Science and Human Nutrition Clinical Research Laboratory — Fort Collins
Identifiers
NCT: NCT07081698 · 6690