Fruit and Vegetable Biomarker Discovery
University of California (UC), Davis Dietary Biomarkers Development Center
University of California, Davis
280 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Body Mass Index (BMI) 18.5-39.9 kg/m\^2
- Willingness to provide urine and have blood drawn
Exclusion Criteria63
- Pregnancy or lactation
- Allergy or aversion to foods provided in test diet
- History of gastrointestinal disorders including the following:
- Ulcerative colitis or Crohn's disease
- Celiac sprue
- Hereditary non-polyposis colorectal cancer (HNPCC)
- Familial adenomatous polyposis
- Pancreatic disease
- 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):
- Protein supplements
- Soy
- Fiber
- Flaxseed
- Fish oil (including cod liver oil)
- Probiotics
- Carotenoids
- Selenium
- Other antioxidants
- Other phytochemicals
- Glucosamine
- 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:
- Fasting Glucose: 54-125 mg/dL
- Urea: 6-50 mg/dL
- Creatinine: 0.4-1.3 mg/dL
- Estimated Glomerular Filtration Rate (eGFR): >60 mL/min
- Sodium: 133-146 mmol/L
- Alanine Transaminase (ALT): 5-60 U/L
- Aspartate Aminotransferase (AST): 5-40 U/L
- Alkaline Phosphatase (ALP): 20-135 U/L
- Total Bilirubin: 0.0-1.9 mg/dL
- Total Protein: 5-9.0 g/dL
- Albumin: 3.5-5.9 d/L
- Low-density Lipoprotein (LDL) Cholesterol: <160 mg/dL
- Triglycerides: <500
- White Blood Cells: 3-10.5 Kl/µL
- Hematocrit: 35-48 g/dL (women), 37.5-49 g/dL (men)
- Current use of the following prescription medications:
- Diuretics
- Steroids (oral): daily oral any dose within 1 month of study (except for oral contraceptive pills)
- Opiates: any use within 1 month of study
- Hypolipidemic 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
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Interventions
A meal challenge will be provided that contains 1 serving of peaches and 2 servings of strawberries as a smoothie and 2 servings of tomatoes and 1 serving of carrot as a vegetable dish.
A meal challenge will be provided that contains 1 serving of banana and 2 servings of peaches as a smoothie and 1 serving of tomatoes and 2 servings of green beans as a vegetable dish.
A meal challenge will be provided that contains 2 serving of bananas and 1 serving of strawberries as a smoothie and 1 serving of green beans and 2 servings of carrots as a vegetable dish.
The diet will provide sufficient calories for weight maintenance and will contain refined grains and low amounts of fruits and vegetables, representative of the typical American diet. No bananas, strawberries, peaches, green beans, carrots, or tomatoes will be provided.
This diet will provide sufficient calories for weight maintenance and will contain refined grains and low amounts of fruits and vegetables, representative of the typical American diet. Bananas, strawberries, peaches, green beans, carrots, and tomatoes will be provided in amounts less than or equal to 1 serving per day each.
This diet will provide sufficient calories for weight maintenance and will contain whole grains and high amounts of fruits and vegetables, representative of the Dietary Guidelines for Americans. Bananas, strawberries, peaches, green beans, carrots, and tomatoes will be provided in amounts greater than or equal to 1 serving per day each.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05621863