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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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....

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fixed Mixed Meal Test

    Other intervention

    a FIXED dose meal that will be 900 kcal of a liquid meal

  • Adjusted Mixed Meal Test

    Other intervention

    a body weight ADJUSTED dose liquid meal. (30% of total daily energy requirements)

Treatment groups

79 Participants
are divided into 2 treatment groups
Group A: 1Active comparator 1 intervention
Group B: 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Glucose AUC associated with MMTT conditions (fixed vs. adjusted).

Time frame
Baseline, Visit 3/4

Secondary outcomes

1

Body Composition

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).

Time frame
Baseline, Visit 3/4
2

Resting Metabolic Rate

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).

Time frame
Baseline, Visit 3/4
3

Lipids

Change in energy expenditure associated with MMTT conditions (fixed vs. adjusted).

Time frame
Baseline, Visit 3/4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.