Developing dietary biomarkers through controlled feeding in healthy adults

Phase 2 Seattle Dietary Biomarkers Development Center (P2-SDBDC)

This study is testing if new ways to measure what people eat can work better than just asking them, by having healthy adults follow different diets and checking their blood, urine, and stool samples.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fred Hutchinson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06656338 on ClinicalTrials.gov

What this trial studies

The Seattle Dietary Biomarker Development Center aims to enhance the measurement of dietary intake by identifying and validating dietary biomarkers that surpass the limitations of self-reported dietary data. This Phase 2 study involves a two-period, crossover, controlled feeding trial with 30 healthy adults, where participants will follow higher and lower Healthy Eating Index (HEI) 2020 diet patterns. Blood, urine, and stool samples will be collected to conduct metabolomics assays for biomarker identification and validation. The study will help determine the detectability of food biomarkers in relation to different dietary patterns.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 years or older with a BMI between 18.5 and 39.9.

Not a fit: Patients who are pregnant, lactating, or have specific gastrointestinal disorders or recent hospital admissions for heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate dietary assessments, improving nutritional guidance and health outcomes for individuals.

How similar studies have performed: Other studies have shown success in identifying dietary biomarkers, but this approach is novel in its specific focus on the Healthy Eating Index and metabolomics.

Eligibility criteria

Inclusion criteria:

* 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

Exclusion criteria:

* 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 this trial is running

Seattle, Washington

• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Marian L. Neuhouser, PhD, RD — Fred Hutchinson Cancer Center
• Study coordinator: Sarah Altvater, MS, RD

Conditions Healthy Adults; Healthy Eating Index-2020; Cross-over trial; Controlled feeding study; Metabolomics