Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose (NCT06223555) | Clinical Trial Compass
RecruitingNot Applicable
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
United States79 participantsStarted 2024-08-23
Plain-language summary
Background:
Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.
Objective:
To learn how fixed vs adjusted meals affect blood glucose levels in healthy people.
Eligibility:
Healthy people aged 18 years or older.
Design:
Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.
Participants will have baseline tests:
Their height, weight, and waist size will be measured.
They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.
They will have a body scan.
Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:
Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.
MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Baseline, Visit 3/4
Trial details
NCT IDNCT06223555
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)