An interventional study of Higher HEI-2020 diet followed by lower HEI-2020 diet and Lower HEI-2020 diet followed by higher HEI-2020 diet in Healthy Adults, sponsored by Marian Neuhouser. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Marian Neuhouser · Not applicable, Interventional, and Other
The Seattle Dietary Biomarker Development Center (S-DBDC) aims to advance the science of measuring dietary intake by identification and validation of dietary biomarkers that improve upon self-reported diet. To accomplish this mission, the Seattle DBDC will carry out controlled feeding studies in healthy human volunteers. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification. Stool samples will be collected and archived.
The central mission of the Seattle Dietary Biomarker Development Center (DBDC) is to advance the science of measuring complex dietary exposures by rigorous identification and validation of dietary biomarkers that improve upon measurement error-prone self-reported diet. To accomplish this mission, the Seattle DBDC first conducted a Phase 1 study for biomarker discovery; the Phase 1 study is registered and reported in a separate clinicaltrials.gov record (NCT05580653) as the study design differs from Phase 2.
In Phase 2 (registered in this current clinicaltrials.gov record), the Seattle DBDC will conduct a two-period, crossover, controlled feeding trial to evaluate whether the food biomarkers discovered in Phase 1 are detectable within the context of higher and lower Healthy Eating Index (HEI) 2020 diet patterns and to discover metabolomic biomarkers of higher and lower HEI-2020 diet patterns. A total of 30 healthy adults will complete two feeding periods in random order. Each feeding period consists of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with at least a 7-day washout between feeding periods. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification and validation. Stool samples will be collected and archived for future studies.
Marian Neuhouser is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Other: Higher HEI-2020 diet followed by lower HEI-2020 diet
Other: Lower HEI-2020 diet followed by higher HEI-2020 diet
Controlled feeding study of HEI-2020 diet. Crossover feeding study of two, 7-day feeding periods with higher HEI-2020 and lower HEI-2020 diets completed in random order.
Controlled feeding study of HEI-2020 diet. Crossover feeding study of two, 7-day feeding periods with higher HEI-2020 and lower HEI-2020 diets completed in random order.
Plasma metabolite concentration at Day 7 for Higher HEI-2020 Diet
Time frame: Day 7
Urine metabolite concentration at Day 7 for Higher HEI-2020 Diet
Time frame: Day 7
Plasma metabolite concentration at Day 7 for Lower HEI-2020 Diet
Time frame: Day 7
Urine metabolite concentration at Day 7 for Lower HEI-2020 Diet
Time frame: Day 7
Plan to share: Yes — We will comply with the NIH Data Sharing Policy. This trial will be registered at ClinicalTrials.gov. We will publish results in peer-reviewed journals. Data generated from this study will be sent to the Data Coordinating Center Center (DCC) at Duke University. The DCC will make study data available to other Consortium members (University of California Davis, Harvard University) in accordance with best practices for data safety and accessibility. Participants' data may be stored and shared for future research without additional informed consent if identifiable private information is removed. Use of participant data may result in commercial profit; however, participants will not be compensated for the use of their data other than what is described in the consent form. The final de-identified study data and results will be made publicly available, in accordance with NIH data sharing policies.
Supporting information: Study protocol, Sap, Icf
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Marian Neuhouser