Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06266689

Project humAn dieTary daTa rEtuRN

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Lawrence David

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized Diet Information

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.

Primary outcomes

  1. Number of participants with diet improvement

    Time frame: 12 months

    The investigators' primary objective is to test the hypothesis that returning DNA metabarcoding data is an effective method for improving diet and increasing dietary diversity.

  2. Number of participants with increased dietary diversity

    Time frame: 12 months

    the investigators' primary objective is to test the hypothesis that returning DNA metabarcoding data is an effective method for improving diet and increasing dietary diversity.

Secondary outcomes

  1. Number of participants with changes in the composition and function of the gut microbiome

    Time frame: 12 months

    Assess whether dietary diversity is associated with the structure and function of the gut microbiome and health outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Jenkins, B.S

CONTACT

[email protected]

9196684736

Lawrence A David, PhD

CONTACT

[email protected]

(919) 668-5388

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effects of Diet Data Return on Human Dietary Patterns

Acronym: PATTERN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.