Walnuts as an Infant Solid Food for Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-5
SponsorColorado State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Adults unable to consent
Pregnant women
Prisoners
Trial design
Design model
Factorial
Treatments tested in this trial
Infant walnut intake
Other interventionThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: The walnut groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Gut 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 months2
Infant Growth (Length)
Measured in cm
Time frame
Over 7 months3
Infant Growth (Weight)
Measured in kg
Time frame
Over 7 months4
Dietary Intake
3 day dietary recall with results generated by NDSR software
Time frame
Over 7 monthsSecondary outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
California Walnut Commission
Collaborator
Source ClinicalTrials.gov