Project humAn dieTary daTa rEtuRN

ConditionDiet Habit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: InterventionOther 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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