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

NCT06223555 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-05-12

No results posted yet for this study

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....

Conditions

Interventions

OTHER

Fixed Mixed Meal Test

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

OTHER

Adjusted Mixed Meal Test

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Susanne M Votruba, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223555 on ClinicalTrials.gov