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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT06223555
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Fixed Mixed Meal Test — OTHER
    a FIXED dose meal that will be 900 kcal of a liquid meal
  • Adjusted Mixed Meal Test — OTHER
    a body weight ADJUSTED dose liquid meal. (30% of total daily energy requirements)

Study Details

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....

Key Dates

Start date
Aug 23, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
79 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: 1
    Fixed Mixed Meal Test
  • Active Comparator: 2
    Adjusted Mixed Meal Test

Primary Outcome Measure

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. [ Time Frame: Baseline, Visit 3/4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIDDK, PhoenixPhoenixArizona85014
Susi Votruba, Ph.D.
[email protected]
602-200-5336

Find similar trials in Phoenix, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
NIDDK, Phoenix· Phoenix, AZ

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