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Meal Testing for Healthy Subjects

N/A

Recruiting

Led By Susi M Votruba, Ph.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Type I or Type II Diabetes Mellitus by self-report

Hematologic disorders including significant anemia (male hemoglobin < 13.0 g/dL or female hemoglobin < 11.0 g/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, visit 3/4

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how different types of meals affect blood glucose levels in healthy people. The researchers want to determine if fixed meals, which are the same size for everyone, or adjusted meals, based

Who is the study for?

This trial is for healthy adults over 18 years old. It's designed to see how different calorie amounts in meals affect blood sugar levels. Participants will need to visit the clinic several times and undergo various tests, including drinking a sugary solution and having their metabolic rate measured.

What is being tested?

Researchers are testing two types of mixed meal tolerance tests (MMTTs): one with a fixed caloric dose for everyone, and another adjusted based on individual body size. The goal is to determine which method provides more accurate results for future studies.

What are the potential side effects?

Since this study involves healthy individuals consuming standard or adjusted meals, side effects are minimal but may include discomfort from blood draws or possible reactions to the liquid meal consumed during the MMTT.

Eligibility Criteria

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 Type I or Type II diabetes.

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My blood tests show I do not have significant anemia.

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I don't take more than 3 grams of acetaminophen daily or can stop it for the study.

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I have a history of serious gut diseases like Crohn's, celiac, or active ulcers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, visit 3/4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, visit 3/4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, visit 3/4 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine whether an adjusted energy dose MMTTor a fixed dosed meal will result in greater variability in glucose area under the curve (AUC) within the same participants across a range of BMIs.

Secondary study objectives

Body Composition

Lipids

Resting Metabolic Rate