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NCT Number: NCT07081698

Walnuts as an Infant Solid Food for Health

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.

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Key information

Conditions

Gut -Microbiota Infant Development Inflammatory Markers

Age range

5 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Nutrition Clinical Research Laboratory

Fort Collins, Colorado, 80523, United States

Location status: Recruiting

About this study

Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant walnut intake

Other

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 outcomes

  1. Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing

    Time frame: Over 7 months

    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).

  2. Infant Growth (Length)

    Time frame: Over 7 months

    Measured in cm

  3. Infant Growth (Weight)

    Time frame: Over 7 months

    Measured in kg

  4. Dietary Intake

    Time frame: Over 7 months

    3 day dietary recall with results generated by NDSR software

  5. IL-33 (Interleukin-33)

    Time frame: Over 7 months

    Measured in pg/mL

  6. IL-6 (Interleukin-6)

    Time frame: Over 7 months

    Measure in pg/mL

  7. IL-8 (Interleukin-8)

    Time frame: Over 7 months

    Measured in pg/mL

  8. IL-13 (Interleukin-13)

    Time frame: Over 7 months

    Measured in pg/mL

  9. TGF-b (Transforming growth factor beta)

    Time frame: Over 7 months

    Measured in ng/ml.

  10. IL-4 (Interleukin-4)

    Time frame: Over 7 months

    Measured in pg/mL

  11. IL-10 (Interleukin 10)

    Time frame: Over 7 months

    Measured in pg/mL

Secondary outcomes

  1. Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis

    Time frame: Over 7 months

    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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • California Walnut Commission

Registry information

Official study title

Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants

Acronym: WISH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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