Walnuts as an Infant Solid Food for Health (WISH)

Colorado State University (CSU)

Status: Enrolling

Conditions: Gut -Microbiota; Inflammatory Markers; Infant Development

Treatments: Other: Infant walnut intake

Study type: Interventional

Funder types: Other

Identifiers

NCT07081698

6690

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 5 to 5 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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90 participants in 2 patient groups

The walnut group

Experimental group

Description:

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

Treatment:

Other: Infant walnut intake

Control Group

No Intervention group

Description:

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