P1-SDBDC: Phase 1 Seattle Dietary Biomarkers Development Center

Sponsor

Marian Neuhouser (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05580653

Collaborator

United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA) (Other), University of Nebraska (Other), University of Washington (Other), Duke University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Other: Controlled feeding study of beef and/or pinto beans Other: Controlled feeding study of eggs and/or black beans	N/A

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 biospecimens will be used for study outcomes and archived for future studies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized cross-overRandomized cross-over

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Statisticians, Laboratory personnel

Primary Purpose:

Other

Official Title:

Phase 1 Seattle Dietary Biomarkers Development Center

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1) Beef then half beef and half pinto bean then pinto bean	Other: Controlled feeding study of beef and/or pinto beans 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.
Experimental: 2) Half pinto bean and half beef then pinto bean then beef	Other: Controlled feeding study of beef and/or pinto beans 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.
Experimental: 3) Pinto Bean then Beef then half pinto bean and half beef	Other: Controlled feeding study of beef and/or pinto beans 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.
Experimental: 4) Egg then half Egg and half black bean then black bean	Other: Controlled feeding study of eggs and/or black beans 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.
Experimental: 5) Half egg and half black bean, then black bean then egg	Other: Controlled feeding study of eggs and/or black beans 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.
Experimental: 6) Black bean then egg then half black bean and half egg	Other: Controlled feeding study of eggs and/or black beans 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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, 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
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-lipemics that affect GI or renal function (ie. Fibrates)
Anti-glycemics other than metformin (ie. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)
Biologics/immune modulators (ie. RA, psoriasis, other rheumatologic/hematologic active disease)
Anti-coagulants (coumadin, heparin, Eliquis, etc.)
HIV/HAART, etc. (dyslipogenic)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

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

Investigators

Principal Investigator: Marian L. Neuhouser, PhD, RD, Fred Hutchinson Cancer Center
Principal Investigator: Johanna W. Lampe, PhD, RD, Fred Hutchinson Cancer Center