Phase 1 Seattle Dietary Biomarkers Development Center

Healthy Adults Clinical Trial

— P1-SDBDC  

Official title:

Phase 1 Seattle Dietary Biomarkers Development Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580653
• Other study ID #: RG1121654
• Secondary ID: USDA-NIFA Grant
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Sarah Altvater, MS, RD
• Phone: 206-667-7091
• Email: fbs[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy adults

2. Age 18 years and older

3. Willing to come to the Fred Hutch campus 16 times during the study

4. BMI 18.5-39.9 kg/m2

Exclusion Criteria:

1. History of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)

2. Bleeding disorder that precludes blood draws

3. Previous gastrointestinal resection or bariatric surgery

4. 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.

5. Cancer under active radiation or chemotherapy treatment (post-6 mos)

6. Pregnant or lactating

7. Weight change (±5% in 3 months)

8. 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

9. Use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vaping devices, etc) and not willing to abstain during feeding periods.

10. Use of illicit drugs and not willing to abstain during feeding periods.

11. BMI =40 kg/m2

12. Seated blood pressure > 140/90 mm Hg

13. Fasting clinical lab tests outside acceptable value as ascertained at a screening blood draw°

14. Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.

15. Current use of specific prescription medication (study staff will review medications to determine eligibility)**

16. Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and unable to stop taking these during feeding periods

17. 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

18. Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)

19. 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:

1. Diuretics

2. Steroids (oral): daily oral any dose within 1 month of study, except OCP as noted below

3. Opiates: any use within 1 month of study

4. Anti-lipid medications that affect GI or renal function (ie. Fibrates)

5. Hyperglycemia medications other than metformin (ie. insulin, SGLT2 inhibitor, a-glucosidase inhibitor)

6. Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)

7. Biologic/immune modulators (ie. RA, psoriasis, other rheumatologic/hematologic active disease)

8. Anti-coagulants (coumadin, heparin, Eliquis, etc.)

9. HIV/HAART, etc. (dyslipidemic)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean metabolite concentration at Day 7 for Beef		Day 7
Primary	Mean metabolite concentration at Day 7 for Pinto Bean		Day 7
Primary	Mean area under the curve of 24-hour metabolite concentration for Beef		0-24 hours
Primary	Mean area under the curve of 24-hour metabolite concentration for Pinto Bean		0-24 hours
Primary	Mean metabolite concentration at Day 7 for Egg		Day 7
Primary	Mean metabolite concentration at Day 7 for Black Bean		Day 7
Primary	Mean area under the curve of 24-hour metabolite concentration for Egg		0-24 hours
Primary	Mean area under the curve of 24-hour metabolite concentration for Black Bean		0-24 hours