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Diet Monitoring Through Biomarkers (UCD-DBDC Trial)

N/A
Recruiting
Led By Carolyn M Slupsky, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how to use markers in blood/urine to measure the intake of fruits/veggies, allowing us to understand the link between diet and health. It could lead to new ways of objectively measuring nutrition.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary interventions rather than medication or invasive procedures, side effects may include digestive discomfort related to diet changes but no severe drug-related side effects are expected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Body Weight Changes
Secondary study objectives
Acute consumption of fruits and vegetables
Diet adherence
Habitual consumption of fruits and vegetables

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Aim 2 Typical American Diet Plus Test FoodsExperimental Treatment1 Intervention
Group II: Aim 2 Typical American DietExperimental Treatment1 Intervention
Group III: Aim 2 Dietary Guidelines for Americans Diet Plus Test FoodsExperimental Treatment1 Intervention
Group IV: Aim 1 Group 6Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 3, Meal Challenge 2, Meal Challenge 1
Group V: Aim 1 Group 5Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 3, Meal Challenge 1, Meal Challenge 2
Group VI: Aim 1 Group 4Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 2, Meal Challenge 1, Meal Challenge 3
Group VII: Aim 1 Group 3Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 2, Meal Challenge 3, Meal Challenge 1
Group VIII: Aim 1 Group 2Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 1, Meal Challenge 3, Meal Challenge 2
Group IX: Aim 1 Group 1Experimental Treatment3 Interventions
Order of Treatments: Meal Challenge 1, Meal Challenge 2, Meal Challenge 3

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,755,850 Total Patients Enrolled
USDA, Western Human Nutrition Research CenterFED
62 Previous Clinical Trials
18,782 Total Patients Enrolled
Carolyn M Slupsky, PhDPrincipal InvestigatorUniversity of California, Davis

Media Library

Aim 1 Group 3 Clinical Trial Eligibility Overview. Trial Name: NCT05621863 — N/A
Biomarkers Research Study Groups: Aim 1 Group 3, Aim 2 Typical American Diet Plus Test Foods, Aim 1 Group 4, Aim 2 Dietary Guidelines for Americans Diet Plus Test Foods, Aim 2 Typical American Diet, Aim 1 Group 1, Aim 1 Group 2, Aim 1 Group 5, Aim 1 Group 6
Biomarkers Clinical Trial 2023: Aim 1 Group 3 Highlights & Side Effects. Trial Name: NCT05621863 — N/A
Aim 1 Group 3 2023 Treatment Timeline for Medical Study. Trial Name: NCT05621863 — N/A
~117 spots leftby Apr 2026
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