RECRUITING

Fruit and Vegetable Biomarker Discovery

Conditions

Biomarkers Metabolomics Diet Fruit Vegetables Biomarker Urine Blood

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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 purpose of this research is to find a set of markers in the blood and/or urine that can be linked to consumption of specific fruits and vegetables. This will allow for better understanding of the link between diet and health-related outcomes. Furthermore, the results of this study will lead to the development of new methods to evaluate the nutritional status of individuals in both community and clinical settings. Food frequency questionnaires and diaries/recalls can be affected by intentional or unintentional misreporting, and thus can create errors in determining nutritional status. This study will lead to the development of an objective way to assess the consumption of specific fruits and vegetables by the general population.

Official Title

University of California (UC), Davis Dietary Biomarkers Development Center

Quick Facts

Study Start:2023-04-01

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05621863

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
* Body Mass Index (BMI) 18.5-39.9 kg/m\^2 * Willingness to provide urine and have blood drawn	* Pregnancy or lactation * Allergy or aversion to foods provided in test diet * History of gastrointestinal disorders including the following: 1. Ulcerative colitis or Crohn's disease 2. Celiac sprue 3. Hereditary non-polyposis colorectal cancer (HNPCC) 4. Familial adenomatous polyposis 5. Pancreatic disease 6. Liver disease * Previous gastrointestinal resection or bariatric surgery * Bleeding disorders that preclude blood draws * Recent hospital admissions (past 6 months) for myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) * Cardiovascular disease (CVD) 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, or vapes and not willing to abstain during feeding periods * Use of illicit drugs and not willing to abstain during feeding periods * BMI \>40 kg/m\^2 * Regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids and unwilling or unable to stop taking these during feeding periods * Regular (daily to weekly) use of OTC 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 (may continue if vitamin supplement is prescribed by a medical doctor): 1. Protein supplements 2. Soy 3. Fiber 4. Flaxseed 5. Fish oil (including cod liver oil) 6. Probiotics 7. Carotenoids 8. Selenium 9. Other antioxidants 10. Other phytochemicals 11. Glucosamine 12. Chondroitin * 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 values outside of the following ranges: 1. Fasting Glucose: 54-125 mg/dL 2. Urea: 6-50 mg/dL 3. Creatinine: 0.4-1.3 mg/dL 4. Estimated Glomerular Filtration Rate (eGFR): \>60 mL/min 5. Sodium: 133-146 mmol/L 6. Alanine Transaminase (ALT): 5-60 U/L 7. Aspartate Aminotransferase (AST): 5-40 U/L 8. Alkaline Phosphatase (ALP): 20-135 U/L 9. Total Bilirubin: 0.0-1.9 mg/dL 10. Total Protein: 5-9.0 g/dL 11. Albumin: 3.5-5.9 d/L 12. Low-density Lipoprotein (LDL) Cholesterol: \<160 mg/dL 13. Triglycerides: \<500 14. White Blood Cells: 3-10.5 Kl/µL 15. Hematocrit: 35-48 g/dL (women), 37.5-49 g/dL (men) * Current use of the following prescription medications: 1. Diuretics 2. Steroids (oral): daily oral any dose within 1 month of study (except for oral contraceptive pills) 3. Opiates: any use within 1 month of study 4. Hypolipidemic agents that affect GI or renal function (ie. fibrates) 5. Hypoglycemic medications other than metformin (ie. insulin, SGLT2 inhibitor, α-glucosidase inhibitor) 6. Psychiatric medications that affect metabolism/renal function (anti-psychotics, lithium) 7. Biologics/immune modulators (ie. rheumatoid arthritis, psoriasis, other rheumatologic/hematologic active disease) 8. Anti-coagulants (coumadin, heparin, Eliquis, etc.) 9. HIV/HAART medications (dyslipidemia inducing) * Inability to freely give informed consent

Inclusion Criteria

Exclusion Criteria

* Body Mass Index (BMI) 18.5-39.9 kg/m\^2
* Willingness to provide urine and have blood drawn

* Pregnancy or lactation
* Allergy or aversion to foods provided in test diet
* History of gastrointestinal disorders including the following:
1. Ulcerative colitis or Crohn's disease
2. Celiac sprue
3. Hereditary non-polyposis colorectal cancer (HNPCC)
4. Familial adenomatous polyposis
5. Pancreatic disease
6. Liver disease
* Previous gastrointestinal resection or bariatric surgery
* Bleeding disorders that preclude blood draws
* Recent hospital admissions (past 6 months) for myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF)
* Cardiovascular disease (CVD) 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, or vapes and not willing to abstain during feeding periods
* Use of illicit drugs and not willing to abstain during feeding periods
* BMI \>40 kg/m\^2
* Regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids and unwilling or unable to stop taking these during feeding periods
* Regular (daily to weekly) use of OTC 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 (may continue if vitamin supplement is prescribed by a medical doctor):
1. Protein supplements
2. Soy
3. Fiber
4. Flaxseed
5. Fish oil (including cod liver oil)
6. Probiotics
7. Carotenoids
8. Selenium
9. Other antioxidants
10. Other phytochemicals
11. Glucosamine
12. Chondroitin
* 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 values outside of the following ranges:
1. Fasting Glucose: 54-125 mg/dL
2. Urea: 6-50 mg/dL
3. Creatinine: 0.4-1.3 mg/dL
4. Estimated Glomerular Filtration Rate (eGFR): \>60 mL/min
5. Sodium: 133-146 mmol/L
6. Alanine Transaminase (ALT): 5-60 U/L
7. Aspartate Aminotransferase (AST): 5-40 U/L
8. Alkaline Phosphatase (ALP): 20-135 U/L
9. Total Bilirubin: 0.0-1.9 mg/dL
10. Total Protein: 5-9.0 g/dL
11. Albumin: 3.5-5.9 d/L
12. Low-density Lipoprotein (LDL) Cholesterol: \<160 mg/dL
13. Triglycerides: \<500
14. White Blood Cells: 3-10.5 Kl/µL
15. Hematocrit: 35-48 g/dL (women), 37.5-49 g/dL (men)
* Current use of the following prescription medications:
1. Diuretics
2. Steroids (oral): daily oral any dose within 1 month of study (except for oral contraceptive pills)
3. Opiates: any use within 1 month of study
4. Hypolipidemic agents that affect GI or renal function (ie. fibrates)
5. Hypoglycemic medications other than metformin (ie. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
6. Psychiatric medications that affect metabolism/renal function (anti-psychotics, lithium)
7. Biologics/immune modulators (ie. rheumatoid arthritis, psoriasis, other rheumatologic/hematologic active disease)
8. Anti-coagulants (coumadin, heparin, Eliquis, etc.)
9. HIV/HAART medications (dyslipidemia inducing)
* Inability to freely give informed consent

Contacts and Locations

Study Contact

Ellen L Bonnel, PhD

CONTACT

530-752-4184

ellen.bonnel@usda.gov

Principal Investigator

Carolyn M Slupsky, PhD

PRINCIPAL_INVESTIGATOR

University of California, Davis

Study Locations (Sites)

USDA ARS Western Human Nutrition Research Center

Davis, California, 95616

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Carolyn M Slupsky, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

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 Date2023-04-01

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

Metabolomics
Diet
Fruit
Vegetables
Biomarker
Urine
Blood

Additional Relevant MeSH Terms

Biomarkers