Fruit and Vegetable Biomarker Discovery
UCD-DBDC
University of California (UC), Davis Dietary Biomarkers Development Center
2 other identifiers
interventional
280
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedJuly 18, 2025
July 1, 2025
3.1 years
November 10, 2022
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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.
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)
Diet adherence
Aim 1: day 3, 8, 13. Aim 2: day 3, 6, and 9.
Habitual consumption of fruits and vegetables
Day 1
Acute consumption of fruits and vegetables
Days 1, 2, 3.
Study Arms (9)
Aim 1 Group 1
EXPERIMENTALOrder of Treatments: Meal Challenge 1, Meal Challenge 2, Meal Challenge 3
Aim 1 Group 2
EXPERIMENTALOrder of Treatments: Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
Aim 1 Group 3
EXPERIMENTALOrder of Treatments: Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
Aim 1 Group 4
EXPERIMENTALOrder of Treatments: Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
Aim 1 Group 5
EXPERIMENTALOrder of Treatments: Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
Aim 1 Group 6
EXPERIMENTALOrder of Treatments: Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
Aim 2 Typical American Diet
EXPERIMENTALAim 2 Typical American Diet Plus Test Foods
EXPERIMENTALAim 2 Dietary Guidelines for Americans Diet Plus Test Foods
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) 18.5-39.9 kg/m\^2
- Willingness to provide urine and have blood drawn
You may not qualify if:
- 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)
- +48 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA ARS Western Human Nutrition Research Center
Davis, California, 95616, United States
Related Publications (1)
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.
PMID: 40641655DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn M Slupsky, PhD
University of California, Davis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 18, 2022
Study Start
April 1, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be embargoed until publications are complete, at which time they will be made available to the scientific community.
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.