Phase 1 Seattle Dietary Biomarkers Development Center

NCT05580653 | Completed DMC

• 2 other identifiers: RG1121654USDA-NIFA 2022-67017-38475
• Study Type: interventional
• Target: 30
• 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.

Conditions

Healthy Adults

Keywords

Healthy Diet; Diet; Red meat; Eggs; Pinto beans; Black beans; Pharmacokinetics; Metabolomics

Outcome Measures

Primary Outcomes (8)

• Mean metabolite concentration at Day 7 for Beef

  Day 7

• Mean metabolite concentration at Day 7 for Pinto Bean

  Day 7

• Mean area under the curve of 24-hour metabolite concentration for Beef

  0-24 hours

• Mean area under the curve of 24-hour metabolite concentration for Pinto Bean

  0-24 hours

• Mean metabolite concentration at Day 7 for Egg

  Day 7

• Mean metabolite concentration at Day 7 for Black Bean

  Day 7

• Mean area under the curve of 24-hour metabolite concentration for Egg

  0-24 hours

• Mean area under the curve of 24-hour metabolite concentration for Black Bean

  0-24 hours

Study Arms (6)

1) Beef then half beef and half pinto bean then pinto bean

EXPERIMENTAL

Other: Controlled feeding study of beef and/or pinto beans

2) Half pinto bean and half beef then pinto bean then beef

EXPERIMENTAL

Other: Controlled feeding study of beef and/or pinto beans

3) Pinto Bean then Beef then half pinto bean and half beef

EXPERIMENTAL

Other: Controlled feeding study of beef and/or pinto beans

4) Egg then half Egg and half black bean then black bean

EXPERIMENTAL

Other: Controlled feeding study of eggs and/or black beans

5) Half egg and half black bean, then black bean then egg

EXPERIMENTAL

Other: Controlled feeding study of eggs and/or black beans

6) Black bean then egg then half black bean and half egg

EXPERIMENTAL

Other: Controlled feeding study of eggs and/or black beans

Interventions

Controlled feeding study of beef and/or pinto beans OTHER

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.

1) Beef then half beef and half pinto bean then pinto bean; 2) Half pinto bean and half beef then pinto bean then beef; 3) Pinto Bean then Beef then half pinto bean and half beef

Controlled feeding study of eggs and/or black beans OTHER

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.

4) Egg then half Egg and half black bean then black bean; 5) Half egg and half black bean, then black bean then egg; 6) Black bean then egg then half black bean and half egg

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 and older
• Willing to come to the Fred Hutch campus 16 times during the study
• BMI 18.5-39.9 kg/m2

You may not qualify if:

• History of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)
• Bleeding disorder that precludes blood draws
• Previous gastrointestinal resection or bariatric surgery
• Recent hospital admissions (in past 6 months) for heart disease (myocardial Infarction/cerebrovascular accident or congestive heart failure) or other cardiovascular disease/coronary artery disease condition under physician guided therapy that is not medically stable.
• Cancer under active radiation or chemotherapy treatment (post-6 mos)
• Pregnant or lactating
• Weight change (±5% in 3 months)
• Regular alcohol intake of \>2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits) and unwilling to abstain during feeding periods
• Use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vaping devices, 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
• Seated blood pressure \> 140/90 mm Hg
• Fasting clinical lab tests outside acceptable value as ascertained at a screening blood draw°
• Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.
• Current use of specific prescription medication (study staff will review medications to determine eligibility)\*\*

Sponsors & Collaborators

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

Study Sites (1)

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, Mishchuk DO, Bain JR, He X, Sun J, Harnly J, Simmons W, Raftery D, Liang L, Newman JW, Fiehn O, Clish CB, Lampe JW, Bennett BJ, Navarro SL, Wang Y, Zheng C, Mossavar-Rahmani Y, McCullough ML, Huang Y, Shojaie A, Zhu W, Djukovic D, Sacks F, Williams J, Steinberg FM, Adams SH, Hu FB, Neuhouser ML, Slupsky CM, Maruvada P. The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition. Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.

  PMID: 40641655 DERIVED

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 12, 2022
• First Posted: October 14, 2022
• Study Start: March 2, 2023
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

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

Locations

US (1)