Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-05-18
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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The walnut group
The intervention group will provide 10g of walnuts daily to their infant for 7 months.
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.
Control Group
The control group will be asked to limit walnuts and tree nuts.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Prisoners
5 Months
5 Months
ALL
No
Sponsors
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California Walnut Commission
OTHER
Colorado State University
OTHER
Responsible Party
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Principal Investigators
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Minghua Tang, Phd
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Locations
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Food Science and Human Nutrition Clinical Research Laboratory
Fort Collins, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6690
Identifier Type: -
Identifier Source: org_study_id
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