RECRUITING

Phase 2 Seattle Dietary Biomarkers Development Center

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06656338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Sarah Altvater, MS, RD

CONTACT

206-667-7091

fbs@fredhutch.org

Marian L. Neuhouser, PhD, RD

CONTACT

206-667-4797

fbs@fredhutch.org

Principal Investigator

Marian L. Neuhouser, PhD, RD

PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Johanna W. Lampe, PhD, RD

PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Study Locations (Sites)

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Marian Neuhouser

Marian L. Neuhouser, PhD, RD, PRINCIPAL_INVESTIGATOR, Fred Hutchinson Cancer Center
Johanna W. Lampe, PhD, RD, PRINCIPAL_INVESTIGATOR, Fred Hutchinson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-03

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Healthy Adults