Project humAn dieTary daTa rEtuRN

Recruiting now · Not applicable

Conditions studied: Diet Habit

In brief

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.

Key facts

Study ID

NCT06266689

Run by

Duke University

People needed

600

Starts

2024-02-27

Expected to finish

2026-12-01

Last updated by the study team

2026-01-29

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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