Gut -Microbiota, Infant Development, Inflammatory Markers
Conditions
Keywords
Walnut, Microbiome, Infant, Pediatric, Nutrition, Health
Brief 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.
Interventions
OTHERInfant 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.
Sponsors
California Walnut Commission
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 5 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-10 (Interleukin 10) | Over 7 months | Measured in pg/mL |
| Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing | Over 7 months | 16S rRNA amplicon sequencing is used to profile taxonomic makeup of fecal specimens. Within the gut microbiome composition, microbial diversity will be summarized using common ecological measures (Good's coverage, Sobs, and Shannon alpha diversity). |
| Infant Growth (Length) | Over 7 months | Measured in cm |
| Infant Growth (Weight) | Over 7 months | Measured in kg |
| Dietary Intake | Over 7 months | 3 day dietary recall with results generated by NDSR software |
| IL-33 (Interleukin-33) | Over 7 months | Measured in pg/mL |
| IL-6 (Interleukin-6) | Over 7 months | Measure in pg/mL |
| IL-8 (Interleukin-8) | Over 7 months | Measured in pg/mL |
| IL-13 (Interleukin-13) | Over 7 months | Measured in pg/mL |
| TGF-b (Transforming growth factor beta) | Over 7 months | Measured in ng/ml. |
| IL-4 (Interleukin-4) | Over 7 months | Measured in pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis | Over 7 months | Metabolomics analysis (nutri-metabolomics) is used to identify and validate food-derived biomarkers that may be classified as biomarkers of intake and/or biomarkers of effect, both of which can be linked to health indicators. |
Countries
United States
Contacts
Primary ContactNathan Campbell, MS
Backup ContactKinzie Matzeller, MS RDNCLC
Outcome results
None listed