Phase 2 Seattle Dietary Biomarkers Development Center

NCT06656338 | Completed DMC

• 2 other identifiers: RG1124404FHIRB0020415
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 diet

EXPERIMENTAL

Other: Higher HEI-2020 diet followed by lower HEI-2020 diet

Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 diet

EXPERIMENTAL

Other: Lower HEI-2020 diet followed by higher HEI-2020 diet

Interventions

Higher HEI-2020 diet followed by lower HEI-2020 diet OTHER

Controlled feeding study of HEI-2020 diet. Crossover feeding study of two, 7-day feeding periods with higher HEI-2020 and lower HEI-2020 diets completed in random order.

Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 diet

Lower HEI-2020 diet followed by higher HEI-2020 diet OTHER

Controlled feeding study of HEI-2020 diet. Crossover feeding study of two, 7-day feeding periods with higher HEI-2020 and lower HEI-2020 diets completed in random order.

Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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);

Sponsors & Collaborators

• Marian Neuhouser: lead
• Duke University: collaborator
• University of Nebraska: collaborator
• University of Washington: collaborator
• United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA): collaborator

Study Sites (1)

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Study Officials

• Marian L. Neuhouser, PhD, RD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Johanna W. Lampe, PhD, RD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statisticians Laboratory personnel
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cancer Prevention Program Head

Model Details: Randomized cross-over

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: March 18, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)