Healthy AdultsP2-SDBDCNCT06656338
Phase 2 Seattle Dietary Biomarkers Development Center
A study testing Higher HEI-2020 diet followed by lower HEI-2020 diet and Lower HEI-2020 diet followed by higher HEI-2020 diet in people with Healthy Adults, run by Marian Neuhouser at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Higher HEI-2020 diet followed by lower HEI-2020 diet and Lower HEI-2020 diet followed by higher HEI-2020 diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 27 Feb 2026
- 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 or older;
- Willing to come to the Fred Hutch campus 10 times during the study; BMI 18.5-39.9 kg/m2
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: Phase 2 Seattle Dietary Biomarkers Development Center (P2-SDBDC)
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.
Read the detailed description
The central mission of the Seattle Dietary Biomarker Development Center (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 first conducted a Phase 1 study for biomarker discovery; the Phase 1 study is registered and reported in a separate clinicaltrials.gov record (NCT05580653) as the study design differs from Phase 2.
In Phase 2 (registered in this current clinicaltrials.gov record), the Seattle DBDC will conduct a two-period, crossover, controlled feeding trial to evaluate whether the food biomarkers discovered in Phase 1 are detectable within the context of higher and lower Healthy Eating Index (HEI) 2020 diet patterns and to discover metabolomic biomarkers of higher and lower HEI-2020 diet patterns. A total of 30 healthy adults will complete two feeding periods in random order. Each feeding period consists of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with at least a 7-day washout between feeding periods. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification and validation. Stool samples will be collected and archived for future studies.
- Conditions
- Healthy Adults
- Being tested
- Higher HEI-2020 diet followed by lower HEI-2020 diet, Lower HEI-2020 diet followed by higher HEI-2020 diet
- Keywords
- Healthy Eating Index-2020, Cross-over trial, Controlled feeding study, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher HEI-2020 diet followed by lower HEI-2020 dietOther
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.
Lower HEI-2020 diet followed by higher HEI-2020 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 diet | Experimental | Not described Receives: Other: Higher HEI-2020 diet followed by lower HEI-2020 diet |
| Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 diet | Experimental | Not described Receives: Other: Lower HEI-2020 diet followed by higher HEI-2020 diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma metabolite concentration at Day 7 for Higher HEI-2020 Diet
Measured: Day 7
Urine metabolite concentration at Day 7 for Higher HEI-2020 Diet
Measured: Day 7
Plasma metabolite concentration at Day 7 for Lower HEI-2020 Diet
Measured: Day 7
Urine metabolite concentration at Day 7 for Lower HEI-2020 Diet
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start18 Mar 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marian Neuhouser
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), University of Nebraska, University of Washington, Duke University
- Responsible party
- Sponsor-investigator, Marian Neuhouser, Fred Hutchinson Cancer Center
- Investigators
- Marian L. Neuhouser, PhD, RD, Principal investigator, Fred Hutchinson Cancer CenterJohanna W. Lampe, PhD, RD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656338
- Sponsor's protocol ID
- RG1124404
- Other IDs
- FHIRB0020415
- Acronym
- P2-SDBDC
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 13 Apr 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Seattle Dietary Biomarkers Development Center (P2-SDBDC)
- ClinicalTrials.gov ID
- NCT06656338
- Acronym / sponsor ID
- P2-SDBDC / RG1124404
- Conditions
- Healthy Adults
- Keywords
- Healthy Eating Index-2020, Cross-over trial, Controlled feeding study, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 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
- 18 Mar 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 24 Oct 2024 (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.
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.
Detailed description
The central mission of the Seattle Dietary Biomarker Development Center (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 first conducted a Phase 1 study for biomarker discovery; the Phase 1 study is registered and reported in a separate clinicaltrials.gov record (NCT05580653) as the study design differs from Phase 2.
In Phase 2 (registered in this current clinicaltrials.gov record), the Seattle DBDC will conduct a two-period, crossover, controlled feeding trial to evaluate whether the food biomarkers discovered in Phase 1 are detectable within the context of higher and lower Healthy Eating Index (HEI) 2020 diet patterns and to discover metabolomic biomarkers of higher and lower HEI-2020 diet patterns. A total of 30 healthy adults will complete two feeding periods in random order. Each feeding period consists of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with at least a 7-day washout between feeding periods. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification and validation. Stool samples will be collected and archived for future studies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized cross-over
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| Higher HEI-2020 diet followed by lower HEI-2020 dietControlled 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. | Other | Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 diet |
| Lower HEI-2020 diet followed by higher HEI-2020 dietControlled 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. | Other | Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 diet |
Primary outcome
Plasma metabolite concentration at Day 7 for Higher HEI-2020 Diet
Time frame: Day 7
Urine metabolite concentration at Day 7 for Higher HEI-2020 Diet
Time frame: Day 7
Plasma metabolite concentration at Day 7 for Lower HEI-2020 Diet
Time frame: Day 7
Urine metabolite concentration at Day 7 for Lower HEI-2020 Diet
Time frame: Day 7
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 13 Apr 2026.
- 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 testing Higher HEI-2020 diet followed by lower HEI-2020 diet and Lower HEI-2020 diet followed by higher HEI-2020 diet in people with 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 3 inclusion and 17 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 13 Apr 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?
Plasma metabolite concentration at Day 7 for Higher HEI-2020 Diet (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.