Gut -MicrobiotaWISHNCT07081698
Walnuts as an Infant Solid Food for Health
A study testing Infant walnut intake in people with Gut -Microbiota and Inflammatory Markers, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 5 months
- Conditions the study is for
- Gut -Microbiota, Inflammatory Markers, Infant Development
- What is being tested?
- Infant walnut intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kinzie Matzeller, MS RDNCLC contact
United States1 site, 1 recruiting
- Recruiting
Food Science and Human Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523
Nathan Campbell, M.S., 7655436716, Nathan.Campbell@colostate.edu
Kinzie Matzeller, M.S., RDN, CLC, kinzie.matzeller@colostate.edu
About this study
Official title: Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
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.
Read the detailed 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.
- Conditions
- Gut -Microbiota, Inflammatory Markers, Infant Development
- Being tested
- Infant walnut intake
- Keywords
- Walnut, Microbiome, Infant, Pediatric, Nutrition, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant walnut intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The walnut group | Experimental | The intervention group will provide 10g of walnuts daily to their infant for 7 months. Receives: Other: Infant walnut intake |
| Control Group | No intervention | The control group will be asked to limit walnuts and tree nuts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
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).
Measured: Over 7 months
Infant Growth (Length)
Measured in cm
Measured: Over 7 months
Infant Growth (Weight)
Measured in kg
Measured: Over 7 months
Dietary Intake
3 day dietary recall with results generated by NDSR software
Measured: Over 7 months
IL-33 (Interleukin-33)
Measured in pg/mL
Measured: Over 7 months
IL-6 (Interleukin-6)
Measure in pg/mL
Measured: Over 7 months
IL-8 (Interleukin-8)
Measured in pg/mL
Measured: Over 7 months
IL-13 (Interleukin-13)
Measured in pg/mL
Measured: Over 7 months
TGF-b (Transforming growth factor beta)
Measured in ng/ml.
Measured: Over 7 months
IL-4 (Interleukin-4)
Measured in pg/mL
Measured: Over 7 months
IL-10 (Interleukin 10)
Measured in pg/mL
Measured: Over 7 months
Secondary outcomes (1)
Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
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.
Measured: Over 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start18 May 2025
- Primary completionDec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut -MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Sponsor
- Investigators
- Minghua Tang, Phd, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081698
- Sponsor's protocol ID
- 6690
- Acronym
- WISH
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
- ClinicalTrials.gov ID
- NCT07081698
- Acronym / sponsor ID
- WISH / 6690
- Conditions
- Gut -Microbiota, Inflammatory Markers, Infant Development
- Keywords
- Walnut, Microbiome, Infant, Pediatric, Nutrition, Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- 18 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The walnut group | Experimental | Other: Infant walnut intakeThe intervention group will provide 10g of walnuts daily to their infant for 7 months. |
| Control Group | No intervention | –The control group will be asked to limit walnuts and tree nuts. |
Who may qualify
- Ages
- 5 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Adults unable to consent
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant walnut intakeThe 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. | Other | The walnut group |
Primary outcome
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).
Infant Growth (Length)
Time frame: Over 7 months
Measured in cm
Infant Growth (Weight)
Time frame: Over 7 months
Measured in kg
Dietary Intake
Time frame: Over 7 months
3 day dietary recall with results generated by NDSR software
IL-33 (Interleukin-33)
Time frame: Over 7 months
Measured in pg/mL
IL-6 (Interleukin-6)
Time frame: Over 7 months
Measure in pg/mL
IL-8 (Interleukin-8)
Time frame: Over 7 months
Measured in pg/mL
IL-13 (Interleukin-13)
Time frame: Over 7 months
Measured in pg/mL
TGF-b (Transforming growth factor beta)
Time frame: Over 7 months
Measured in ng/ml.
IL-4 (Interleukin-4)
Time frame: Over 7 months
Measured in pg/mL
IL-10 (Interleukin 10)
Time frame: Over 7 months
Measured in pg/mL
1 secondary outcome
Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
Time frame: Over 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kinzie Matzeller, MS RDNCLC contact
Minghua Tang, Phd principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant walnut intake in people with Gut -Microbiota and Inflammatory Markers, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Campbell, MS (7655436716, Nathan.Campbell@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing (time frame: Over 7 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.