Phase 2 Seattle Dietary Biomarkers Development Center

Completed · Not applicable

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT06656338

Run by

Marian Neuhouser

People needed

32

Starts

2025-03-18

Expected to finish

2026-02-27

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults;
• Age 18 years or older;
• Willing to come to the Fred Hutch campus 10 times during the study; BMI 18.5-39.9 kg/m2

You may not qualify if…

• Pregnancy or lactation;
• allergy or aversion to any of the foods that will be studied and/or provided;
• history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease;
• previous gastrointestinal resection or bariatric surgery;
• bleeding disorders that precludes blood draws;
• recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy that is not medically stable;
• cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment;
• weight change (±5% in the last 3 months);
• regular alcohol intake of > 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits), and unwilling to abstain during feeding periods;
• use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc) and not willing to abstain during feeding periods;
• use of illicit drugs and not willing to abstain during feeding periods;
• BMI ≥40 kg/m2; regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids or anti-inflammatories, and unwilling or unable to stop taking these during feeding periods;
• unwilling to stop taking OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (including cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine and chondroitin (if vitamin supplement is MD prescribed - may continue);
• oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics);
• seated blood pressure >140/90 mmHg; fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw (see Table 2 in protocol document);
• current use of specific prescription medication(s) (see Table 3 in protocol document); and
• inability to freely give informed consent.

Where it is running

• Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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