NCT06266689

Project humAn dieTary daTa rEtuRN

Effects of Diet Data Return on Human Dietary Patterns

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Diet Habit

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Diet Information	These participants will receive a report detailing their genomic food data based on the investigators' DNA metabarcoding technique in addition to standard dietary guidance to see if receiving the report modifies what they choose to feed their infant.

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-20
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States