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Walnuts as an Infant Solid Food for Health

NCT07081698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Gut -Microbiota
  • Inflammatory Markers
  • Infant Development

Interventions

OTHER

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.

Sponsors & Collaborators

  • California Walnut Commission

    collaborator OTHER

  • Colorado State University

    lead OTHER

Principal Investigators

  • Minghua Tang, Phd · Colorado State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
5 Months
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081698 on ClinicalTrials.gov