Actively Recruiting

Phase Not Applicable
Age: 0 - 12Months
All Genders
Healthy Volunteers
NCT06266689

Project humAn dieTary daTa rEtuRN

Led by Duke University · Updated on 2026-01-29

600

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Project humAn dieTary daTa rEtuRN

Who Can Participate

Age: 0 - 12Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Health conditions that impact the infant feeding in a way that may confound interpretation of study results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

L

Lawrence A David, PhD

CONTACT

K

Kirsten Jenkins, B.S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Project humAn dieTary daTa rEtuRN | DecenTrialz