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BiomarkersUCD-DBDCNCT05621863

Fruit and Vegetable Biomarker Discovery

A study testing Aim 1 Meal Challenge 1, Aim 1 Meal Challenge 2 and Aim 1 Meal Challenge 3 in people with Biomarkers, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Biomarkers
What is being tested?
Aim 1 Meal Challenge 1, Aim 1 Meal Challenge 2 and Aim 1 Meal Challenge 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to 13 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 63Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USDA ARS Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

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

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.

Read the detailed 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.

This study includes 3 aims to identify and then validate urine and plasma biomarkers associated with fruit and vegetable intake. Aim 1 will use a randomized crossover dietary intervention to determine the dose and time response of metabolites in plasma and urine associated with exposure to a mixture of MyPlate fruits and vegetables. Aim 2 will use a parallel design, controlled diet intervention to determine whether the biomarkers of fruit and vegetable intake determined in Aim 1 are predictors of consumption in the context of a defined dietary pattern. Aim 3 will be a cross-sectional validation arm that determines if the biomarkers of food intake developed in Aims 1 and 2 have predictive value reflecting recent and habitual consumption of these foods in a heterogeneous and diverse population.

Conditions
Biomarkers
Being tested
Aim 1 Meal Challenge 1, Aim 1 Meal Challenge 2, Aim 1 Meal Challenge 3, Aim 2 Typical American Diet, Aim 2 Typical American Diet Plus Test Foods
Keywords
Metabolomics, Diet, Fruit, Vegetables, Biomarker, Urine, Blood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aim 1 Meal Challenge 1Other

    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.

  • Aim 1 Meal Challenge 2Other

    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.

  • Aim 1 Meal Challenge 3Other

    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.

  • Aim 2 Typical American DietOther

    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.

  • Aim 2 Typical American Diet Plus Test FoodsOther

    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.

  • Aim 2 Dietary Guidelines for Americans Diet Plus Test FoodsOther

    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.

Study groups in NCT05621863
Study groupRoleWhat they receive
Aim 1 Group 1ExperimentalOrder of Treatments: Meal Challenge 1, Meal Challenge 2, Meal Challenge 3
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 1 Group 2ExperimentalOrder of Treatments: Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 1 Group 3ExperimentalOrder of Treatments: Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 1 Group 4ExperimentalOrder of Treatments: Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 1 Group 5ExperimentalOrder of Treatments: Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 1 Group 6ExperimentalOrder of Treatments: Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
Receives: Other: Aim 1 Meal Challenge 1; Other: Aim 1 Meal Challenge 2; Other: Aim 1 Meal Challenge 3
Aim 2 Typical American DietExperimentalNot described
Receives: Other: Aim 2 Typical American Diet
Aim 2 Typical American Diet Plus Test FoodsExperimentalNot described
Receives: Other: Aim 2 Typical American Diet Plus Test Foods
Aim 2 Dietary Guidelines for Americans Diet Plus Test FoodsExperimentalNot described
Receives: Other: Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urine metabolomics profile

    Urine metabolites will be measured by ultra-performance liquid chromatography mass spectrometry (UPLC-MS) before and after consumption of no, low, or high doses of study fruits and vegetables. Change will be assessed by the appearance of and change in levels of dietary-derived metabolites, which are candidate dietary biomarkers.

    Measured: Aim 1: day 3, 8, 13; overnight fasted and post prandial 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-24 hours. Aim 2: day 3, 9, 10; Aim 3: day 4.

  2. Change in plasma metabolomics profile

    Plasma metabolites will be measured by ultra-performance liquid chromatography mass spectrometry (UPLC-MS) before and after consumption of no, low, or high doses of study fruits and vegetables. Change will be assessed by the appearance of and change in levels of dietary-derived metabolites, which are candidate dietary biomarkers.

    Measured: Aim 1: day 3, 8, 13; overnight fasted and post prandial 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 7 hour, 8 hour, 24 hour. Aim 2: days 3, 9, 10. Aim 3: day 4.

Secondary outcomes (3)

  1. Diet adherence

    Intake of test and non-test meals/foods will be monitored through weigh-backs by study personnel in Aim 1 and participant self report in Aim 2 to identify deviations in intake of fruits/vegetables of interest.

    Measured: Aim 1: day 3, 8, 13. Aim 2: day 3, 6, and 9.

  2. Habitual consumption of fruits and vegetables

    3-month General Nutrition Assessment Food Frequency Questionnaires (GNA FFQ) will be administered at site visit 1 for each aim.

    Measured: Day 1

  3. Acute consumption of fruits and vegetables

    An Automated Self-Administered 24-Hour (ASA24) 3-day food record will be obtained over 2 weekdays and 1 weekend day during Aim 3.

    Measured: Days 1, 2, 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start1 Apr 2023
  3. Primary completion13 Mar 2026
  4. Study completion13 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Model description
Aim 1: crossover, Aim 2: parallel, Aim 3: observational
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621863
Sponsor's protocol ID
1788772
Other IDs
2021-67017-35783
Acronym
UCD-DBDC
Status last verified
May 2026
First submitted
10 Nov 2022
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) will be sent to the Data Coordinating Center (DCC) at Duke University. The DCC will make study data available to other Consortium members, including researchers at Fred Hutchinson Cancer Center and Harvard, and their affiliates in accordance with best practices for data safety and accessibility. The data may be stored and shared for future research without additional informed consent provided all identifiable private information, such as the subject's name or other identifying information are removed. Once identifying information is removed from the data, we will no longer be able to identify and destroy data belonging to participants who wish to remove their samples from future research. The final de-identified study data and results will be made publicly available, in accordance with National Institutes of Health (NIH) data sharing policies.

Publications

  • Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, Mishchuk DO, Bain JR, He X, Sun J, Harnly J, Simmons W, Raftery D, Liang L, Newman JW, Fiehn O, Clish CB, Lampe JW, Bennett BJ, Navarro SL, Wang Y, Zheng C, Mossavar-Rahmani Y, McCullough ML, Huang Y, Shojaie A, Zhu W, Djukovic D, Sacks F, Williams J, Steinberg FM, Adams SH, Hu FB, Neuhouser ML, Slupsky CM, Maruvada P. The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition. Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.

    PubMed 40641655

Questions about this trial

What is this clinical trial studying?

A study testing Aim 1 Meal Challenge 1, Aim 1 Meal Challenge 2 and Aim 1 Meal Challenge 3 in people with Biomarkers, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 63 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in urine metabolomics profile (time frame: Aim 1: day 3, 8, 13; overnight fasted and post prandial 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-24 hours. Aim 2: day 3, 9, 10; Aim 3: day 4.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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