Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05621863

Fruit and Vegetable Biomarker Discovery

Led by University of California, Davis · Updated on 2025-07-18

280

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

U

USDA, Western Human Nutrition Research Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fruit and Vegetable Biomarker Discovery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body Mass Index (BMI) between 18.5 and 39.9 kg/m2
  • Willingness to provide urine samples and have blood drawn
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Allergy or dislike to foods provided in the test diet
  • History of gastrointestinal disorders such as ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, pancreatic disease, or liver disease
  • Previous gastrointestinal surgery or bariatric surgery
  • Bleeding disorders preventing blood draws
  • Hospital admission in past 6 months for heart attack, stroke, or heart failure
  • Unstable cardiovascular disease under physician care
  • Active cancer treatment or treatment within last 6 months
  • Weight change greater than 5% in last 3 months
  • Regular alcohol use over 2 drinks per day and unwilling to abstain during feeding periods
  • Use of tobacco, marijuana, hookahs, e-cigarettes, or vapes and unwilling to abstain during feeding periods
  • Use of illicit drugs and unwilling to abstain during feeding periods
  • Body Mass Index over 40 kg/m2
  • Regular use of over-the-counter weight-loss aids and unwilling or unable to stop during feeding periods
  • Regular use of over-the-counter anti-inflammatory drugs and unwilling or unable to stop during feeding periods
  • Unwillingness to stop certain dietary supplements that interfere with test foods unless prescribed by a doctor, including protein supplements, soy, fiber, flaxseed, fish oil, probiotics, carotenoids, selenium, antioxidants, phytochemicals, glucosamine, and chondroitin
  • Use of oral or IV antibiotics in past 6 months (may delay participation until 6 months after finishing antibiotics)
  • Seated blood pressure over 140/90 mmHg
  • Fasting laboratory values outside specified healthy ranges for glucose, urea, creatinine, kidney function, sodium, liver enzymes, bilirubin, protein, albumin, LDL cholesterol, triglycerides, white blood cells, and hematocrit
  • Current use of certain prescription medications including diuretics, oral steroids within 1 month (except contraceptives), opiates within 1 month, specific cholesterol and blood sugar medications, psychiatric drugs affecting metabolism, immune modulators, anticoagulants, and certain HIV medications
  • Inability to provide informed consent freely and voluntarily

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

USDA ARS Western Human Nutrition Research Center

Davis, California, United States, 95616

Actively Recruiting

Loading map...

Research Team

E

Ellen L Bonnel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here