90 Participants Needed

Walnuts for Infant Health

(WISH Trial)

NC
KM
Overseen ByKinzie Matzeller, MS RDNCLC
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Colorado State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how eating walnuts might affect gut health, inflammation, skin conditions like eczema, and allergies in breastfed infants. Researchers are also examining how walnuts could influence growth and weight gain in babies. In the study, one group of infants will consume a small amount of walnuts daily, while another group will avoid walnuts and other tree nuts. Suitable candidates for this trial are full-term, generally healthy infants who have been exclusively breastfed with little to no solid food introduced. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential health benefits of walnuts for infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that walnut consumption is safe for infants?

Research has shown that walnuts are generally a healthy food. They contain high levels of beneficial fats, such as omega-3 fatty acids, which are important for health. The FDA has approved walnuts as a healthy food, indicating they are safe for most people to consume.

However, walnuts, like other tree nuts, can cause allergies. Tree nuts rank among the most common foods that trigger allergic reactions in babies. Introducing them slowly and monitoring for signs of allergies, such as skin rashes or difficulty breathing, is important.

Most people can consume walnuts without issues when eaten in normal amounts. For babies, it is crucial to follow guidelines and introduce them carefully to monitor for any adverse reactions.12345

Why are researchers excited about this trial?

Most treatments for boosting infant health focus on supplements or fortified foods. But researchers are excited about using walnuts because they are a natural, whole-food option that may offer multiple benefits. Walnuts are rich in omega-3 fatty acids, which are crucial for brain development, as well as antioxidants that support overall health. Unlike processed supplements, walnuts provide these nutrients in a natural form, which might be better absorbed by infants. This approach could offer a simple, nutritious way to enhance infant health without the need for artificial additives.

What evidence suggests that walnuts might be an effective treatment for infant health?

Research suggests that walnuts may benefit gut health and reduce inflammation. One study found that a diet rich in walnuts during pregnancy improved children's brain development. Another study showed that walnuts aided brain development in teenagers. Although direct evidence for infants is lacking, these findings suggest walnuts might support healthy growth and possibly lower allergy risks. In this trial, the walnut group will give their infant 10g of walnuts daily for 7 months to explore these potential benefits further. Meanwhile, the control group will limit walnuts and tree nuts.16789

Who Is on the Research Team?

MT

Minghua Tang, Phd

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for breastfed infants to see if eating walnuts affects their gut bacteria, inflammation, skin health, and allergy risks. It also looks at how walnuts might influence growth and weight. Infants with certain health conditions or dietary restrictions may not be eligible.

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)
See 1 more

Exclusion Criteria

Pregnant women
Prisoners
I am unable to give consent for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants in the experimental group receive 10g of walnuts daily for 7 months to assess effects on gut microbiota, growth, and immune markers

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Walnuts
Trial Overview The study tests the introduction of walnuts into an infant's diet during early complementary feeding. Researchers will monitor changes in gut microbiota, inflammatory markers, skin health (atopic dermatitis), allergies, growth patterns, and potential risk of becoming overweight.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: The walnut groupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

California Walnut Commission

Collaborator

Trials
25
Recruited
36,700+

Citations

NCT07081698 | Walnuts as an Infant Solid Food for HealthThe objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy ...
Walnuts as an Infant Solid Food for HealthThe objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy ...
Study Finds Eating a Walnut-Enriched Diet During ...Study Finds Eating a Walnut-Enriched Diet During Pregnancy Improves Child Neurodevelopment ... In a study published in JAMA Network Open, ...
Research reveals consuming walnuts during pregnancy ...Research reveals consuming walnuts during pregnancy significantly improves neurodevelopmental outcomes in two-year-olds · Get News App · Get ...
Effect of walnut consumption on neuropsychological ...Thus, this study provides valuable insights and a basis for future scientific research on the effect of walnuts on adolescent brain development.
Walnuts are a “Healthy” Food According to the U.S. Food & ...The total fat in walnuts (18g) is mostly comprised of polyunsaturated fats (13g/oz), including omega-3 ALA (2.5g/oz), an essential fatty acid ...
Nuts For Babies Study: protocol for a randomised ...Nuts For Babies Study: protocol for a randomised controlled trial in Australia investigating if the risk of developing peanut and cashew nut ...
Walnuts for Babies: Nutritional Facts, Health Benefits & ...Walnut; Solid Starts; https://solidstarts.com/foods/walnut/. 2. Nuts, walnuts, English; Food Data Central; U.S. Department of Agriculture; https://fdc.nal ...
To feed or not to feed? Food allergy prevention in infantsNinety percent of allergic reactions are attributed to milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat, also known as the eight ...
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