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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Body Composition
Lipids
Resting Metabolic Rate

Trial Design

2Treatment groups
Active Control
Group I: 2Active Control1 Intervention
Adjusted Mixed Meal Test
Group II: 1Active Control1 Intervention
Fixed Mixed Meal Test

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,409 Previous Clinical Trials
4,324,813 Total Patients Enrolled
Susi M Votruba, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4 Previous Clinical Trials
871 Total Patients Enrolled
~64 spots leftby Jun 2026
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