Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656338
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Phase 2 Seattle Dietary Biomarkers Development Center
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Seattle Dietary Biomarkers Development Center P2-SDBDC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P2-SDBDC
Brief Summary:
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
Detailed Description:
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 clinicaltrialsgov record NCT05580653 as the study design differs from Phase 2
In Phase 2 registered in this current clinicaltrialsgov 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
In Phase 2 registered in this current clinicaltrialsgov 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None