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Meal Effects on Nutrient Tracking (Microdialysis Trial)

N/A

Recruiting

Led By Nicolaas Deutz, MD, PhD

Research Sponsored by Texas A&M University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to walk, sit down and stand up independently

Age 50-75 years old

Must not have

Established diagnosis of malignancy

Established diagnosis of Insulin or non-Insulin Dependent Diabetes Mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 hours per study visit, up to 4 visits

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how the food we eat affects the levels of certain markers in our blood and tissue fluid. It will also test new devices and algorithms to track individual nutrient levels in real time.

Who is the study for?

This trial is for individuals with diabetes and issues with amino acid metabolism. Participants should be willing to fast before study days, undergo body measurements like weight and height, and have their diet, physical activity, and quality of life assessed.

What is being tested?

The trial aims to link the intake of specific macronutrients (proteins, fats, carbohydrates) in meals to changes in blood markers. It tests if wearable devices can track these nutrients effectively by using four different meal sets labeled A through D.

What are the potential side effects?

Since this study involves dietary assessment rather than medication or invasive procedures, side effects are minimal but may include discomfort from fasting or minor reactions to the wearable device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk, sit, and stand on my own.

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I am between 50 and 75 years old.

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I can lie on my back or slightly raised for about 13 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cancer.

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I have been diagnosed with diabetes.

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I have never been treated for liver or kidney diseases.

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I am currently taking blood thinners.

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I have a history of blood clots or clotting disorders.

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I have a severe illness or an unstable chronic condition.

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I have not had a heart attack in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 hours per study visit, up to 4 visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 hours per study visit, up to 4 visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 hours per study visit, up to 4 visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose metabolism

Secondary study objectives

Amino acid metabolism

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy male older adultsExperimental Treatment4 Interventions

Eight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content.

Group II: Healthy female older adultsExperimental Treatment4 Interventions

0 / 10Eligibility criteria met