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Recruiting
NCT05621863
Fruit and Vegetable Biomarker Discovery
Conditions: Biomarkers
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 280
Sponsor: University of California, Davis
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Body Mass Index (BMI) 18.5-39.9
kg/m^2Willingness to provide urine and have blood drawnExclusion Criteria:Pregnancy or lactationAllergy or aversion to foods provided in test dietHistory of gastrointestinal disorders including the following:Ulcerative colitis or Crohn's diseaseCeliac sprueHereditary non-polyposis colorectal cancer (HNPCC)Familial adenomatous polyposisPancreatic diseaseLiver diseasePrevious gastrointestinal resection or bariatric surgeryBleeding disorders that preclude blood drawsRecent 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 stableCancer under radiation or chemotherapy treatment that is active or within 6 months of treatmentWeight 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 periodsUse of tobacco and/or marijuana, hookahs, e-cigarettes, or vapes and not willing to abstain during feeding periodsUse of illicit drugs and not willing to abstain during feeding periodsBMI >40 kg/m^2Regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids and unwilling or unable to stop taking these during feeding periodsRegular (daily to weekly) use of OTC anti-inflammatories and unwilling or unable to stop taking these during feeding periodsUnwilling 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):Protein supplementsSoyFiberFlaxseedFish oil (including cod liver oil)ProbioticsCarotenoidsSeleniumOther antioxidantsOther phytochemicalsGlucosamineChondroitinOral 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 mmHgFasting clinical lab values outside of the following ranges:Fasting Glucose: 54-125 mg/dLUrea: 6-50 mg/dLCreatinine: 0.4-1.3 mg/dLEstimated Glomerular Filtration Rate (eGFR): >60 mL/minSodium: 133-146 mmol/LAlanine Transaminase (ALT): 5-60 U/LAspartate Aminotransferase (AST): 5-40 U/LAlkaline Phosphatase (ALP): 20-135 U/LTotal Bilirubin: 0.0-1.9 mg/dLTotal Protein: 5-9.0 g/dLAlbumin: 3.5-5.9 d/LLow-density Lipoprotein (LDL) Cholesterol: <160 mg/dLTriglycerides: <500White Blood Cells: 3-10.5 Kl/µLHematocrit: 35-48 g/dL (women), 37.5-49 g/dL (men)Current use of the following prescription medications:DiureticsSteroids (oral): daily oral any dose within 1 month of study (except for oral contraceptive pills)Opiates: any use within 1 month of studyHypolipidemic agents that affect GI or renal function (ie.
fibrates)Hypoglycemic medications other than metformin (ie.
insulin, SGLT2 inhibitor, α-glucosidase inhibitor)Psychiatric medications that affect metabolism/renal function (anti-psychotics, lithium)Biologics/immune modulators (ie.
rheumatoid arthritis, psoriasis, other rheumatologic/hematologic active disease)Anti-coagulants (coumadin, heparin, Eliquis, etc.)HIV/HAART medications (dyslipidemia inducing)Inability to freely give informed consent
Source: ClinicalTrials.gov (NCT05621863). StuddyBuddy aggregates publicly available trial information.