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Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits, 2 visits
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks."
  • "Blood samples will be taken from the tube at intervals up to 3 hours after the drink."
  • "Participants will have 2 MMTT visits."
  • "Blood samples will be taken at intervals for the next 4 hours...."
  • "Study Description: This study will be an outpatient study completed in 3-4 separate visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares meal tests that give everyone the same calories with tests that adjust calories to each person’s energy needs. Researchers want to learn how these meals affect blood sugar in healthy adults age 18 or older.

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....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Be healthy based on your health history, a physical exam, and lab tests.
  • Sign and date a form agreeing to take part.
  • Agree to follow the study’s lifestyle rules throughout the study.

Who can't join

  • Use medicines, supplements, or other treatments known to change how your body uses energy.
  • Have blood sugar of 126 mg/dL or higher after fasting, or report having type 1 or type 2 diabetes.
  • Have a blood disorder, including significant anemia (too little hemoglobin, which carries oxygen): below 13 g/dL for men or 11 g/dL for women.
  • Are pregnant, were pregnant within the past 6 months, or are breastfeeding.
  • Have a stomach or bowel disease that may change how your body uses or absorbs the study food, or a food allergy or intolerance that prevents you from having it.
  • Have a score of 8 points on the AUDIT alcohol screening, which the study uses to identify alcohol abuse.
  • Take more than 3 grams of acetaminophen daily and cannot stop it for 24 hours before and after meal tests.
  • Have another condition the study team decides rules you out, or cannot or will not follow study rules. This includes issues that could affect safety or participation, such as fear of enclosed spaces.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \>= 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.

Study sites (1)

AZ