Duke University
Durham, North Carolina, 27705, United States
Location status: Recruiting
Location contact
Lawrence David
CONTACT
NCT Number: NCT06266689
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.
Interested in participating?
Request InfoUp to 12 month
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Location status: Recruiting
Lawrence David
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
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.
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.
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.
Time frame: 12 months
Assess whether dietary diversity is associated with the structure and function of the gut microbiome and health outcomes.
Contact information is provided by the study sponsor or research team.
Kirsten Jenkins, B.S
CONTACT
Lawrence A David, PhD
CONTACT
Duke University
Other
Effects of Diet Data Return on Human Dietary Patterns
Acronym: PATTERN
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.
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