Walnuts as an Infant Solid Food for Health
WISH
Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedStudy Start
First participant enrolled
May 18, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 23, 2025
July 1, 2025
2.5 years
February 27, 2025
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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).
Over 7 months
Infant Growth (Length)
Measured in cm
Over 7 months
Infant Growth (Weight)
Measured in kg
Over 7 months
Dietary Intake
3 day dietary recall with results generated by NDSR software
Over 7 months
IL-33 (Interleukin-33)
Measured in pg/mL
Over 7 months
IL-6 (Interleukin-6)
Measure in pg/mL
Over 7 months
IL-8 (Interleukin-8)
Measured in pg/mL
Over 7 months
IL-13 (Interleukin-13)
Measured in pg/mL
Over 7 months
TGF-b (Transforming growth factor beta)
Measured in ng/ml.
Over 7 months
IL-4 (Interleukin-4)
Measured in pg/mL
Over 7 months
IL-10 (Interleukin 10)
Measured in pg/mL
Over 7 months
Secondary Outcomes (1)
Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
Over 7 months
Study Arms (2)
The walnut group
EXPERIMENTALThe intervention group will provide 10g of walnuts daily to their infant for 7 months.
Control Group
NO INTERVENTIONThe control group will be asked to limit walnuts and tree nuts.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Adults unable to consent
- Pregnant women
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colorado State Universitylead
- California Walnut Commissioncollaborator
Study Sites (1)
Food Science and Human Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Minghua Tang, Phd
Colorado State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2025
First Posted
July 23, 2025
Study Start
May 18, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share