Comparing fixed and adjusted meal tests for blood glucose response
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
This study is testing whether giving people fixed or adjusted meal sizes affects their blood sugar levels differently during a mixed meal tolerance test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 79 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06223555 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two methods of administering mixed meal tolerance tests (MMTTs) to determine which method—fixed caloric doses or adjusted caloric doses based on individual body size—results in greater variability in blood glucose levels. Healthy participants aged 18 and older will undergo 3 to 4 clinic visits over 8 weeks, where they will have their height, weight, and waist size measured, followed by an oral glucose tolerance test. Blood samples will be collected to assess glucose response and other metabolic parameters, helping to identify the most effective MMTT approach for future research.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 years or older.
Not a fit: Patients with diabetes, significant hematologic disorders, or gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of meal tolerance tests, leading to better understanding and management of obesity and metabolic health.
How similar studies have performed: While the approach of comparing fixed versus adjusted meal tests is not widely studied, similar methodologies have shown promise in understanding metabolic responses in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form. * Agreement to adhere to Lifestyle Considerations throughout study duration. * Males and females; Age \>= 18years * Healthy, as determined by medical history, physical examination, and laboratory tests. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism. * Fasting plasma glucose \>= 126 mg/dL * 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) * Current pregnancy, pregnancy within the past 6 months or currently lactating * History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report * Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults. * Participants who report taking large doses of acetaminophen (\> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study. * Inability to consume provided food based on a food allergy or intolerance. * Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. * Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator s and/or team s opinion, jeopardizes the safety of the participant or others or would interfere with adherence to the protocol (such as claustrophobia). Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.
Where this trial is running
Phoenix, Arizona
- NIDDK, Phoenix — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Susanne M Votruba, Ph.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Susanne M Votruba, Ph.D.
- Email: votrubas@niddk.nih.gov
- Phone: (301) 827-3521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.