Diet Monitoring Through Biomarkers

(UCD-DBDC Trial)

Overseen By Ellen L Bonnel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Diuretics, Steroids, Opiates, others

Disqualifiers: Pregnancy, Gastrointestinal disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specific fruits and vegetables appear in blood and urine to better understand diet and health connections. By identifying these markers, researchers aim to create a more accurate method for assessing dietary intake beyond self-reported food diaries. Participants will follow different meal plans, such as the Aim 1 Meal Challenge and the Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods, to help identify these markers. This study suits individuals who can provide blood and urine samples and do not have serious gastrointestinal conditions or major recent medical issues. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research on diet and health.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants using specific prescription medications like diuretics, steroids, opiates, and others affecting metabolism or renal function. Additionally, you must stop using over-the-counter weight-loss aids, anti-inflammatories, and certain dietary supplements during feeding periods.

What prior data suggests that this method is safe for diet monitoring?

Research has shown that eating fruits and vegetables is generally safe, and these foods are being tested in this study. The study aims to identify markers in blood and urine that indicate which fruits and vegetables a person has consumed. This involves controlled meal challenges and diets based on American dietary guidelines.

The specific fruits and vegetables under study include bananas, peaches, strawberries, tomatoes, green beans, and carrots. These are common foods that people consume daily without issues. The study uses diets that adhere to guidelines set by the U.S. Department of Agriculture and Health and Human Services, which are considered safe.

No risky drugs or treatments are involved in this study. Instead, it focuses on understanding how these foods affect the body. Participants can feel comfortable knowing the study involves regular foods that are part of a typical diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how diet monitoring through biomarkers could revolutionize personalized nutrition. Unlike traditional dietary guidelines, which often provide broad recommendations, this approach uses biological markers in the body to tailor diet plans specifically to an individual's unique makeup. This could lead to more effective dietary interventions, helping people achieve better health outcomes by understanding how different foods impact their bodies on a personal level. The trial also compares various meal challenges and diets, potentially uncovering new insights into how specific foods and dietary patterns influence health.

What evidence suggests that this trial's treatments could be effective?

Research has shown that checking certain substances in the blood or urine, known as biomarkers, can provide a clearer picture of fruit and vegetable consumption. Scientists aim to identify these biomarkers to better understand the impact of diet on health. In this trial, participants will join different groups to test various meal challenges and diets, such as the "Aim 1 Meal Challenges" and "Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods." For instance, one study attempts to link specific markers in the blood and urine to the consumption of foods like bananas and strawberries. This method is considered more accurate than traditional methods like food diaries, which can be unreliable due to inaccurate reporting. Understanding these biomarkers can also enhance dietary advice and health outcomes. Although this research continues, using biomarkers to evaluate diet appears promising. ^{2 6 7 8 9}

Who Is on the Research Team?

Carolyn M Slupsky, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 18.5-39.9 who are willing to have blood drawn and provide urine samples. It's not for those recently hospitalized for heart or stroke issues, active cancer patients, those with significant weight changes, high blood pressure, certain abnormal lab values, gastrointestinal disorders, heavy drinkers, or users of various medications including anti-inflammatories and antibiotics.

Inclusion Criteria

Body Mass Index (BMI) 18.5-39.9 kg/m^2

Willingness to provide urine and have blood drawn

Exclusion Criteria

Unwilling to stop taking OTC dietary supplements that interfere with the test foods being studied

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Aim 1: Randomized Crossover Dietary Intervention

Determine the dose and time response of metabolites in plasma and urine associated with exposure to a mixture of MyPlate fruits and vegetables.

2 weeks

Multiple visits for meal challenges and sample collection

Aim 2: Parallel Design Controlled Diet Intervention

Determine whether the biomarkers of fruit and vegetable intake are predictors of consumption in the context of a defined dietary pattern.

2 weeks

Multiple visits for diet adherence monitoring and sample collection

Aim 3: Cross-sectional Validation

Validate if the biomarkers of food intake have predictive value reflecting recent and habitual consumption of these foods in a diverse population.

1 week

Visits for sample collection and dietary assessments

Follow-up

Participants are monitored for safety and effectiveness after the interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aim 1 Meal Challenge 1
• Aim 1 Meal Challenge 2
• Aim 1 Meal Challenge 3
• Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods
• Aim 2 Typical American Diet
• Aim 2 Typical American Diet Plus Test Foods

Trial Overview The study aims to identify markers in the blood/urine that indicate fruit and vegetable consumption. Participants will follow different diets: some typical American diets with or without test foods and others based on Dietary Guidelines plus test foods.

How Is the Trial Designed?

Group I: Aim 2 Typical American Diet Plus Test Foods Experimental Treatment 1 Intervention

Group II: Aim 2 Typical American Diet Experimental Treatment 1 Intervention

Group III: Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods Experimental Treatment 1 Intervention

Group IV: Aim 1 Group 6 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 3, Meal Challenge 2, Meal Challenge 1

Group V: Aim 1 Group 5 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 3, Meal Challenge 1, Meal Challenge 2

Group VI: Aim 1 Group 4 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 2, Meal Challenge 1, Meal Challenge 3

Group VII: Aim 1 Group 3 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 2, Meal Challenge 3, Meal Challenge 1

Group VIII: Aim 1 Group 2 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 1, Meal Challenge 3, Meal Challenge 2

Group IX: Aim 1 Group 1 Experimental Treatment 3 Interventions

Order of Treatments: Meal Challenge 1, Meal Challenge 2, Meal Challenge 3

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

USDA, Western Human Nutrition Research Center

Collaborator

Trials

64

Recruited

19,100+

Published Research Related to This Trial

The 2015 Dietary Guidelines for Americans (DGA) were developed through a comprehensive process involving systematic literature reviews and public input, focusing on dietary patterns and their impact on health outcomes for individuals aged 2 and older.

Key recommendations from the report include addressing overconsumed nutrients like sodium and added sugars, promoting healthy dietary patterns, and endorsing physical activity guidelines to improve overall public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 2015 Dietary Guidelines Advisory Committee Scientific Report: Development and Major Conclusions. Millen, BE., Abrams, S., Adams-Campbell, L., et al.[2023]

In a 12-week study involving 63 African American adults at risk for type 2 diabetes, all three US Dietary Guidelines dietary patterns (Healthy US-Style, Mediterranean, and Vegetarian) resulted in significant weight loss, but there were no significant differences in outcomes between the groups.

While all diets led to weight loss, the Mediterranean diet group showed greater improvements in dietary quality compared to the Vegetarian group, indicating that while weight loss was similar, the Mediterranean diet may offer additional benefits in terms of nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-Week Randomized Intervention Comparing the Healthy US, Mediterranean, and Vegetarian Dietary Patterns of the US Dietary Guidelines for Changes in Body Weight, Hemoglobin A1c, Blood Pressure, and Dietary Quality among African American Adults. Turner-McGrievy, GM., Wilson, MJ., Carswell, J., et al.[2023]

A systematic review of 96 studies found that carotenoids and vitamin C are the most reliable biomarkers for measuring fruit and vegetable intake, which can help assess compliance in dietary interventions.

For studies focusing solely on fruit intake, measuring vitamin C alone may be sufficient, highlighting the importance of tailored biomarker selection based on the type of dietary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of fruit and vegetable intake in human intervention studies: a systematic review. Baldrick, FR., Woodside, JV., Elborn, JS., et al.[2021]

Incorporating recommended amounts of vegetables into the diets of adults with overweight and obesity led to significant improvements in diet quality, as indicated by a 4.48 point increase in Healthy Eating Index scores, while also reducing the intake of grains, protein foods, saturated fats, and added sugars.

Participants reported using 29% of the provided vegetables as substitutes for other foods, but there was no overall change in total energy intake or body weight, suggesting that increasing vegetable consumption can enhance diet quality without leading to weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating the Dietary Guidelines for Americans Vegetable Recommendations into the Diet Alters Dietary Intake Patterns of Other Foods and Improves Diet Quality in Adults with Overweight and Obesity. Casperson, SL., Jahns, L., Duke, SE., et al.[2022]

The DASH trial, a 4-year multicenter outpatient study, successfully developed and implemented standardized 7-day cycle menus across four clinical centers to compare the effects of different dietary patterns on blood pressure.

The study highlights the importance of meticulous planning in menu design and food production to ensure consistency and adherence to nutrient criteria, which is crucial for the success of controlled feeding studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menu design and selection for multicenter controlled feeding studies: process used in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. Swain, JF., Windhauser, MM., Hoben, KP., et al.[2019]

A multi-biomarker panel, including Proline betaine, Hippurate, and Xylose, was developed to accurately classify individuals based on their fruit intake, demonstrating its potential to enhance dietary assessments.

In a study involving 565 participants, the biomarker panel showed excellent agreement with self-reported fruit intake, indicating that this approach could improve the accuracy of dietary evaluations and help distinguish between different food consumption levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Multi-Biomarker Panels in Nutrition Research: Total Fruit Intake as an Example. McNamara, AE., Walton, J., Flynn, A., et al.[2021]

Dietary biomarkers are useful tools for assessing dietary intake, but current methods primarily focus on single nutrients or individual foods rather than specific dietary patterns.

There are no established dietary biomarkers that can accurately identify the specific dietary patterns consumed by individuals, highlighting the need for future research to develop and validate comprehensive biomarker panels that reflect the complexity of dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of dietary patterns: a systematic review of randomized controlled trials. Liang, S., Nasir, RF., Bell-Anderson, KS., et al.[2022]

The 19-item Eating Assessment Tool (EAT) was developed and validated, showing a strong correlation (r=0.73) with the Healthy Eating Index (HEI) score, indicating its effectiveness in assessing dietary habits related to health and cardiovascular risk.

The EAT was successfully reduced to a 9-item Mini-EAT, which maintains predictive ability (r=0.71) and can be used as a quick dietary screener in clinical settings, making it practical for improving patient health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). Lara-Breitinger, KM., Medina Inojosa, JR., Li, Z., et al.[2023]

A review of food-based dietary guidelines (FBDGs) from 30 countries in the Americas revealed that 93% use illustrations that reflect local traditions and classify foods into six or seven main groups, emphasizing the importance of cultural relevance in nutrition education.

Despite cultural differences, the FBDGs share common nutritional messages, such as the importance of consuming plenty of fruits, vegetables, and cereals while limiting fats, sugars, and salt, although they often lack specific guidance for different population needs, especially in areas facing both obesity and malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

North and South American countries food-based dietary guidelines: A comparison. Montagnese, C., Santarpia, L., Iavarone, F., et al.[2019]

The National Center for Food Safety and Technology (NCFST) is focusing on improving health and reducing disease risk by using emerging technologies to enhance food quality and consumer choice, as highlighted in a recent workshop with experts from various fields.

The workshop identified key challenges in personalized nutrition and developed a research agenda aimed at creating individualized food-based solutions that are more accessible and affordable, ultimately supporting the implementation of the US Dietary Guidelines for Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of innovation and technology in meeting individual nutritional needs. Lewis, KD., Burton-Freeman, BM.[2023]

A study involving 61 fifth-grade children from a rural Northern Plains American-Indian reservation identified key barriers to following the Dietary Guidelines for Americans, including personal preferences and environmental factors like cost and accessibility.

Facilitators that could help improve adherence included community-based suggestions, such as gardening and peer encouragement, indicating that tailored dietary interventions should focus on specific barriers and facilitators for each food group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to following the Dietary Guidelines for Americans reported by rural, Northern Plains American-Indian children. Jahns, L., McDonald, L., Wadsworth, A., et al.[2023]

Increasing daily intake of fruits, vegetables, and juices from about 3 to 8 portions significantly raised levels of beneficial nutrients like vitamin C and carotenoids in participants over a 12-week period.

Despite the increase in nutrient levels, the intervention did not lead to significant improvements in antioxidant capacity or markers of vascular health, indicating that simply consuming more fruits and vegetables may not directly translate to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of increasing fruit and vegetable intake by dietary intervention on nutritional biomarkers and attitudes to dietary change: a randomised trial. Duthie, SJ., Duthie, GG., Russell, WR., et al.[2018]

The Dietary Guidelines for Americans (DGAs) have consistently recommended increasing fruits, vegetables, and whole grains while reducing saturated fats, sugars, and sodium since 1980, but these recommendations often face controversy, particularly from food producers affected by 'eat less' advice.

The 2017 review by the National Academy of Medicine aims to improve the guideline development process, yet ongoing scientific support for reducing certain food groups will likely keep the guidelines politically contentious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Challenges and Controversial Issues in the Dietary Guidelines for Americans, 1980-2015. Nestle, M.[2023]

An 8-week study involving 52 overweight and obese women found that following a Dietary Guidelines for Americans (DGA) diet led to a significant reduction in systolic blood pressure by approximately 9 mm Hg, indicating potential cardiovascular benefits.

However, neither the DGA diet nor the typical American diet (TAD) had an impact on fasting insulin, glucose levels, or lipid profiles, suggesting that simply changing dietary patterns may not affect these metabolic markers in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Krishnan, S., Adams, SH., Allen, LH., et al.[2023]

Citations

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Fruit and Vegetable Biomarker Study - Davis The study aims to identify biomarkers in blood and urine related to fruit and vegetable intake, specifically bananas, peaches, strawberries, ...

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NCT05621863 | Fruit and Vegetable Biomarker Discovery 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.

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Dietary Biomarker Development Center (DBDC) AIM 2 We hope to identify biomarkers in the blood and urine that provide information about fruit and vegetable intake. We will be specifically ...

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The Dietary Biomarkers Development Consortium The DBDC aims to significantly expand the list of validated biomarkers of intake for foods consumed in the United States diet, which can help ...

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Diet Monitoring Through Biomarkers (UCD-DBDC Trial) 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.

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The Dietary Biomarkers Development Consortium: An ... To achieve this goal, a 3-phase approach will be implemented to identify, evaluate, and validate food biomarkers. In phase 1, 3 controlled feeding trial designs ...

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Artificial intelligence in food and nutrition evidence Establishing scientific recommendations for chronic disease risk reduction through food and nutrition presents an enormous data challenge. This is due to the ...

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Investigating the Postprandial Metabolome after Challenge ... This review focuses on how metabolomics can improve the evaluation of the metabolic response in humans during nutritional challenges.