Testing how returning diet data affects eating habits
Effects of Diet Data Return on Human Dietary Patterns
This study is testing if giving people personalized diet information based on their stool samples can help them change their eating habits and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06266689 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of returning personalized diet data on dietary habits among participants. Using a biomarker-based assessment method, participants will provide stool samples to assess their diet and receive feedback on their dietary patterns. The study will involve infants, children, and adults, with a focus on how these dietary changes may influence gut microbiome structure and overall health outcomes. Participants will supply stool samples before and after receiving their diet data to measure any changes in eating behavior.
Who should consider this trial
Good fit: Ideal candidates include parents or legal guardians of infants under 12 months who can provide stool samples and understand English.
Not a fit: Patients with health conditions that could confound dietary interpretation or pose risks during the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary habits and health outcomes for participants.
How similar studies have performed: While the approach of returning diet data is innovative, similar studies have shown promise in influencing dietary behavior through feedback mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Lawrence A David, PhD
- Email: lawrence.david@duke.edu
- Phone: (919) 668-5388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.