Phase 2 Seattle Dietary Biomarkers Development Center

Not Applicable

Recruiting

• Conditions: Healthy Adults

• Registration Number: NCT06656338
• Lead Sponsor: Marian Neuhouser

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 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.

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Status Verified: 2025-03
• Study Start: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-03
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma metabolite concentration at Day 7 for Higher HEI-2020 Diet	Day 7
Urine metabolite concentration at Day 7 for Higher HEI-2020 Diet	Day 7
Plasma metabolite concentration at Day 7 for Lower HEI-2020 Diet	Day 7
Urine metabolite concentration at Day 7 for Lower HEI-2020 Diet	Day 7

Trial Locations

Locations (1)

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States