Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
Recruiting
N/AInterventional Study
ObesityHealthy Volunteer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
79 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for
This trial is looking for healthy adults aged 18 and older to see how different meal sizes affect blood sugar levels. Participants will attend 3 or 4 visits over 8 weeks where they will complete tests and consume meals of different sizes.
Are You a Good Fit for This Trial?
Must not be takingAcetaminophen
Rules you outType 1 diabetesType 2 diabetesSignificant anemiaGastrointestinal diseasesAlcohol abuse
You may be able to join if
I am at least 18 years old
I am healthy according to a medical exam
I can provide signed consent
I agree to follow the study guidelines
You may not be able to join if
I have diabetes or high fasting blood sugar
I am currently pregnant or breastfeeding
I have a significant blood disorder or anemia
I have a history of gastrointestinal diseases
I abuse alcohol
I cannot stop taking high doses of acetaminophen
I have a food allergy that prevents me from consuming the meals
I have a condition that could affect my safety in the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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....
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Eligibility 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 \>= 18year…
* 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.
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