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

University of California, Davis1 site in 1 country280 target enrollmentApril 1, 2023

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2023

End Date

August 31, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of California, Davis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Change in plasma metabolomics profile

Time Frame: 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.

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.

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.

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.