Diet Monitoring Through Biomarkers

(UCD-DBDC Trial)

Overseen by Carolyn M Slupsky, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

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

Disqualifiers: Pregnancy, Gastrointestinal disorders, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this 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. 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.

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 data supports the idea that Diet Monitoring Through Biomarkers is an effective treatment?

The available research shows that increasing fruit and vegetable intake can improve health outcomes. For example, one study found that eating more fruits and vegetables is linked to a lower risk of diseases like heart disease and cancer. Another study highlighted that following the Dietary Guidelines for Americans, which includes eating more vegetables, can improve diet quality in adults with overweight and obesity. These findings suggest that monitoring diet through biomarkers, which helps track fruit and vegetable intake, can be an effective way to improve health. ^{1 2 3 4 5}

What safety data exists for the Diet Monitoring Through Biomarkers clinical trial?

The provided research does not directly address safety data for the Diet Monitoring Through Biomarkers clinical trial or its related studies. The abstracts focus on dietary guidelines, challenges in implementing these guidelines, and the role of technology in nutrition. They do not provide specific safety data or evaluations related to the clinical trial or its associated studies. ^{6 7 8 9 10}

Is the treatment in the trial titled 'Diet Monitoring Through Biomarkers' a promising treatment?

Yes, using biomarkers to monitor diet is promising because it can accurately track how much fruit and vegetables people eat. This helps in understanding and improving diet-related health outcomes, like reducing the risk of heart disease and cancer. ^{3 11 12 13 14}

Research Team

Carolyn M Slupsky, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

USDA, Western Human Nutrition Research Center

Collaborator

Trials

64

Recruited

19,100+

Dr. Naomi Fukagawa

USDA, Western Human Nutrition Research Center

Chief Executive Officer since 2021

PhD in Nutritional Biochemistry from Massachusetts Institute of Technology, MD from Northwestern University

Dr. Charles B. Stephensen

USDA, Western Human Nutrition Research Center

Chief Medical Officer since 2021

PhD in Nutrition from an unspecified institution

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. Germany 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of fruit and vegetable intake in human intervention studies: a systematic review. [2021]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The 2015 Dietary Guidelines Advisory Committee Scientific Report: Development and Major Conclusions. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

North and South American countries food-based dietary guidelines: A comparison. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The role of innovation and technology in meeting individual nutritional needs. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential of Multi-Biomarker Panels in Nutrition Research: Total Fruit Intake as an Example. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). [2023]

13. England pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to following the Dietary Guidelines for Americans reported by rural, Northern Plains American-Indian children. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of dietary patterns: a systematic review of randomized controlled trials. [2022]