Recruiting

Walnuts

Sponsor:

Colorado State University

Code:

NCT07081698

Conditions

Gut -Microbiota

Inflammatory Markers

Infant Development

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Infant walnut intake

Study Details

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.

Conditions

Gut -Microbiota

Inflammatory Markers

Infant Development

Study ID

NCT07081698

Start date

May 18, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Adults unable to consent
  • Pregnant women
  • Prisoners

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: The walnut group

The intervention group will provide 10g of walnuts daily to their infant for 7 months.

no intervention: Control Group

The control group will be asked to limit walnuts and tree nuts.

Interventions

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.

Primary outcome measure

  • Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing [ Time Frame: Over 7 months ]
  • Infant Growth (Length) [ Time Frame: Over 7 months ]
  • Infant Growth (Weight) [ Time Frame: Over 7 months ]
  • Dietary Intake [ Time Frame: Over 7 months ]
  • IL-33 (Interleukin-33) [ Time Frame: Over 7 months ]
  • IL-6 (Interleukin-6) [ Time Frame: Over 7 months ]
  • IL-8 (Interleukin-8) [ Time Frame: Over 7 months ]
  • IL-13 (Interleukin-13) [ Time Frame: Over 7 months ]
  • TGF-b (Transforming growth factor beta) [ Time Frame: Over 7 months ]
  • IL-4 (Interleukin-4) [ Time Frame: Over 7 months ]
  • IL-10 (Interleukin 10) [ Time Frame: Over 7 months ]

Central Contacts and Locations

Central contacts

Nathan Campbell, MS

7655436716Nathan.Campbell@colostate.edu

Kinzie Matzeller, MS RDNCLC

kinzie.matzeller@colostate.edu

Locations

Food Science and Human Nutrition Clinical Research Laboratory

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Nathan Campbell, M.S.

7655436716Nathan.Campbell@colostate.edu

Kinzie Matzeller, M.S., RDN, CLC

kinzie.matzeller@colostate.edu

Principal Investigator:

Minghua Tang, Phd.

More Information

Sponsor

Colorado State University

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

  • Walnut
  • Microbiome
  • Infant
  • Pediatric
  • Nutrition
  • Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2025-07-23.