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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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....

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Arizona
NIDDK, Phoenix
RECRUITING
Phoenix
Contact Information
Primary
Susanne M Votruba, Ph.D.
votrubas@niddk.nih.gov
(602) 200-5336
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 79
Treatments
Active_comparator: 1
Fixed Mixed Meal Test
Active_comparator: 2
Adjusted Mixed Meal Test
Related Therapeutic Areas
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov