Project humAn dieTary daTa rEtuRN

NCT ID: NCT06266689

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2026-12-31

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.

Conditions

Diet Habit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Participants in this group will receive the standard infant dietary guidance packet via email or mail and will additionally be presented with their infant's own dietary DNA metabarcoding data from stool samples collected as part of Project HOPE 1000 and this study. Diet data will be returned via electronic report or a paper report mailed to the participant following the visit.

Group Type: OTHER

Personalized Diet Information

Intervention Type: BEHAVIORAL

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.

Control

Participants in this group will receive a dietary information packet via mail or email, which will consist of the sections of the DGA relevant to 12-24 month old children (Included as a supplemental document, "Standard dietary guidance"). This dietary guidance will also be provided at the 18- and 24-month visits. Please note that participants in this arm will receive their personalized diet information at the conclusion of the study.

Group Type: OTHER

Personalized Diet Information

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lawrence A David, PhD

Role: CONTACT

lawrence.david@duke.edu

(919) 668-5388

Kirsten Jenkins, B.S

Role: CONTACT

kirsten.jenkins@duke.edu

9196684736

Facility Contacts

Lawrence David

Role: primary

Other Identifiers

Pro00112671

Identifier Type: -

Identifier Source: org_study_id