Project humAn dieTary daTa rEtuRN

Официальное название

Effects of Diet Data Return on Human Dietary Patterns

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Number of participants with diet improvement [Срок оценки: 12 months]
• Number of participants with increased dietary diversity [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Number of participants with changes in the composition and function of the gut microbiome [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT06266689 · Pro00112671

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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