| NCT ID | NCT06266689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Diet Habit |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-02-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation.
Eligibility Criteria
Inclusion Criteria: * Participant's parent/legal guardian is over age 18 and able to understand English * Plans to remain in the area for the next two years * Primary caregiver for infant less than 12 months old * Able to collect and ship the requested infant stool samples Exclusion Criteria: There will be no specific exclusions for this study. However, the following biospecimens will not be collected for research purposes from individuals who have a condition that, in the opinion of the site investigators and/or providers, would place the subject at unacceptable risk of injury or confound data interpretation; including but not limited to: * Health conditions that impact the infant feeding in a way that may confound interpretation of study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06266689 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Diet Habit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06266689 currently recruiting?
Yes, NCT06266689 is actively recruiting participants. Contact the research team at lawrence.david@duke.edu for enrollment information.
Where is the NCT06266689 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06266689 clinical trial?
NCT06266689 is sponsored by Duke University. The trial plans to enroll 600 participants.