Project humAn dieTary daTa rEtuRN

Diet Habit Clinical Trial

— PATTERN  

Official title:

Effects of Diet Data Return on Human Dietary Patterns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266689
• Other study ID #: Pro00112671
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Lawrence A David, PhD
• Phone: (919) 668-5388
• Email: lawrence.david[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with diet improvement	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.	12 months
Primary	Number of participants with increased dietary diversity	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.	12 months
Secondary	Number of participants with changes in the composition and function of the gut microbiome	Assess whether dietary diversity is associated with the structure and function of the gut microbiome and health outcomes.	12 months