NCT05580653

Phase 1 Seattle Dietary Biomarkers Development Center

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Marian Neuhouser · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The central mission of the Seattle Dietary Biomarker Development (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 will conduct a set of two, randomized, crossover, 3-period controlled feeding trials to develop metabolomics-based blood and urine biomarkers of 4 individual foods (1) beef and pinto beans or 2) eggs and black beans) and determine the dynamic ranges and half-lives of the urinary and blood-based dietary biomarkers. The two trials use the exact same sample protocol and study procedures and will be conducted successively. For each feeding trial, 15 healthy adults will complete three feeding periods in random order (all protein from beef (trial 1) or eggs (trial 2); 1/2 protein from beef (trial 1) or eggs (trial 2); and 1/2 protein from pinto beans (trial 1) or black beans (trial 2); all protein from pinto beans (trial 1) or black beans (trial 2)). Each feeding period will consist of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with about a 7-day washout between feeding periods. Blood and urine specimens will be collected before, at the mid-point, and at the end of each feeding period. In addition, an all-day pharmacokinetic evaluation will be conducted for 2 of the 3 feeding periods (all beef and all pinto beans (trial 1); all eggs and all black beans (trial 2)). Stool samples will be collected before, and at the end of each feeding period and stored for future studies. The collected specimens will be used for study outcomes and archived for future studies.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
OTHER	Controlled feeding study of beef and/or pinto beans	Crossover feeding study of three, 7-day feeding periods with plant and/or animal proteins (beef, pinto beans, and half beef/half pinto beans) completed in random order.
OTHER	Controlled feeding study of eggs and/or black beans	Crossover feeding study of three, 7-day feeding periods with plant and/or animal proteins (eggs, black beans, and half eggs/half black beans) completed in random order.

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-04-17
• Completion: 2025-04-17
• First posted: 2022-10-14
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States