Healthy AdultsP1-SDBDCNCT05580653

Phase 1 Seattle Dietary Biomarkers Development Center

A study of Healthy Adults, run by Marian Neuhouser at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Adults
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2023to 17 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 47Show fewer

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)**
Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and 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 (incl. cod liver oil), probiotics, glucosamine and chondroitin (if vitamin supplement is MD prescribed - may continue). Study staff will review supplements to determine eligibility
Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)
Inability to freely give informed consent.
Fasting clinical lab tests outside acceptable value as ascertained at a screening blood draw:
Description [Acceptable Values]
Glucose-Fasting: Serum Glucose [54-125 mg/dl]
Urea: BUN [6-50mg/dl]
Serum Creatinine [0.4-1.3 mg/dl]
eGFR: estimated GFR [>60ml/min]
Serum Sodium [133-146 mmol/L]
ALT/GPT Liver Enzyme [5-60 U/L]
AST/GOT Liver Enzyme [5-40 U/L]
Alkaline Phosphatase Liver Enzyme [20-135 U/L]
Total Bilirubin Liver Function [0.0-1.9 mg/dl]
Total Serum Protein [5-9.0 g/dl]
Albumin Serum Protein [3.5-5.9 g/dl]
LDL Cholesterol [<160 mg/dl]
Triglycerides [<500 mg/dl]
WBC White Blood Cells [3-10.5 K/uL]
HCT (women) Hematocrit [35-48 g/dl]
HCT (men) Hematocrit [37.5-49 g/dl]
Medication use for exclusion:
Diuretics
Steroids (oral): daily oral any dose within 1 month of study, except OCP as noted below
Opiates: any use within 1 month of study
Anti-lipid medications that affect GI or renal function (ie. Fibrates)
Hyperglycemia medications other than metformin (ie. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)
Biologic/immune modulators (ie. RA, psoriasis, other rheumatologic/hematologic active disease)
Anti-coagulants (coumadin, heparin, Eliquis, etc.)
HIV/HAART, etc. (dyslipidemic)

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Center
Seattle, Washington, 98109

Other trials in United States

About this study

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.

Read the 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
Being tested: Controlled feeding study of beef and/or pinto beans, Controlled feeding study of eggs and/or black beans
Keywords: Healthy Diet, Diet, Red meat, Eggs, Pinto beans, Black beans, Pharmacokinetics, Metabolomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Controlled feeding study of beef and/or pinto beansOther
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.
Controlled feeding study of eggs and/or black beansOther
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.

Study groups in NCT05580653
Study group	Role	What they receive
1) Beef then half beef and half pinto bean then pinto bean	Experimental	Not described Receives: Other: Controlled feeding study of beef and/or pinto beans
2) Half pinto bean and half beef then pinto bean then beef	Experimental	Not described Receives: Other: Controlled feeding study of beef and/or pinto beans
3) Pinto Bean then Beef then half pinto bean and half beef	Experimental	Not described Receives: Other: Controlled feeding study of beef and/or pinto beans
4) Egg then half Egg and half black bean then black bean	Experimental	Not described Receives: Other: Controlled feeding study of eggs and/or black beans
5) Half egg and half black bean, then black bean then egg	Experimental	Not described Receives: Other: Controlled feeding study of eggs and/or black beans
6) Black bean then egg then half black bean and half egg	Experimental	Not described Receives: Other: Controlled feeding study of eggs and/or black beans

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean metabolite concentration at Day 7 for Beef
Measured: Day 7
Mean metabolite concentration at Day 7 for Pinto Bean
Measured: Day 7
Mean area under the curve of 24-hour metabolite concentration for Beef
Measured: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Pinto Bean
Measured: 0-24 hours
Mean metabolite concentration at Day 7 for Egg
Measured: Day 7
Mean metabolite concentration at Day 7 for Black Bean
Measured: Day 7
Mean area under the curve of 24-hour metabolite concentration for Egg
Measured: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Black Bean
Measured: 0-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202317 Apr 2025

First posted14 Oct 2022
Study start2 Mar 2023
Primary completion17 Apr 2025
Study completion17 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy AdultsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized cross-over
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05580653
Sponsor's protocol ID: RG1121654
Other IDs: USDA-NIFA 2022-67017-38475
Acronym: P1-SDBDC
Status last verified: Feb 2026
First submitted: 12 Oct 2022
Last updated: 20 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will comply with the NIH Data Sharing Policy. This trial will be registered at ClinicalTrials.gov. We will publish results in peer-reviewed journals. Data generated from this study will be sent to the Data Coordinating Center Center (DCC) at Duke University. The DCC will make study data available to other Consortium members (University of California Davis, Harvard University) in accordance with best practices for data safety and accessibility. Participants' data may be stored and shared for future research without additional informed consent if identifiable private information is removed. Use of participant data may result in commercial profit; however, participants will not be compensated for the use of their data other than what is described in the consent form. The final de-identified study data and results will be made publicly available, in accordance with NIH data sharing policies.

Publications

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.
PubMed 40641655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Seattle Dietary Biomarkers Development Center
ClinicalTrials.gov ID: NCT05580653
Acronym / sponsor ID: P1-SDBDC / RG1121654
Conditions: Healthy Adults
Keywords: Healthy Diet, Diet, Red meat, Eggs, Pinto beans, Black beans, Pharmacokinetics, Metabolomics
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Marian NeuhouserUniversity, hospital or other
Collaborators: United States Department of Agriculture (USDA), University of Nebraska, University of Washington, Duke University
Study start: 2 Mar 2023 (actual)
Primary completion: 17 Apr 2025 (actual)
Study completion: 17 Apr 2025 (actual)
First posted: 14 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 6
Model description: Randomized cross-over

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (47 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Controlled feeding study of beef and/or pinto beansCrossover 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	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 beansCrossover 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.	Other	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

Primary outcome

Mean metabolite concentration at Day 7 for Beef
Time frame: Day 7
Mean metabolite concentration at Day 7 for Pinto Bean
Time frame: Day 7
Mean area under the curve of 24-hour metabolite concentration for Beef
Time frame: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Pinto Bean
Time frame: 0-24 hours
Mean metabolite concentration at Day 7 for Egg
Time frame: Day 7
Mean metabolite concentration at Day 7 for Black Bean
Time frame: Day 7
Mean area under the curve of 24-hour metabolite concentration for Egg
Time frame: 0-24 hours
Mean area under the curve of 24-hour metabolite concentration for Black Bean
Time frame: 0-24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Derived from this study: PubMed 40641655Chakraborty 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.
Individual participant dataSharing planned: Yes. We will comply with the NIH Data Sharing Policy. This trial will be registered at ClinicalTrials.gov. We will publish results in peer-reviewed journals. Data generated from this study will be sent to the Data Coordinating Center Center (DCC) at Duke University. The DCC will make study data available to other Consortium members (University of California Davis, Harvard University) in accordance with best practices for data safety and accessibility. Participants' data may be stored and shared for future research without additional informed consent if identifiable private information is removed. Use of participant data may result in commercial profit; however, participants will not be compensated for the use of their data other than what is described in the consent form. The final de-identified study data and results will be made publicly available, in accordance with NIH data sharing policies.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marian L. Neuhouser, PhD, RD principal investigator

Fred Hutchinson Cancer Center

Johanna W. Lampe, PhD, RD principal investigator

Fred Hutchinson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Healthy Adults, run by Marian Neuhouser at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean metabolite concentration at Day 7 for Beef (time frame: Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580653, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.