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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
90
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.
Food Science and Human Nutrition Clinical Research Laboratory
Fort Collins, Colorado, United States
RECRUITINGGut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
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).
Time frame: Over 7 months
Infant Growth (Length)
Measured in cm
Time frame: Over 7 months
Infant Growth (Weight)
Measured in kg
Time frame: Over 7 months
Dietary Intake
3 day dietary recall with results generated by NDSR software
Time frame: Over 7 months
IL-33 (Interleukin-33)
Measured in pg/mL
Time frame: Over 7 months
IL-6 (Interleukin-6)
Measure in pg/mL
Time frame: Over 7 months
IL-8 (Interleukin-8)
Measured in pg/mL
Time frame: Over 7 months
IL-13 (Interleukin-13)
Measured in pg/mL
Time frame: Over 7 months
TGF-b (Transforming growth factor beta)
Measured in ng/ml.
Time frame: Over 7 months
IL-4 (Interleukin-4)
Measured in pg/mL
Time frame: Over 7 months
IL-10 (Interleukin 10)
Measured in pg/mL
Time frame: Over 7 months
Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
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.
Time frame: Over 7 months
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