Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT06223555

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

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

79

Participants Needed

1

Research Sites

122 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form.
  • Willingness to follow lifestyle guidelines during the study.
  • Male or female aged 18 years or older.
  • Considered healthy based on medical history, physical exam, and lab tests.
Not Eligible

You will not qualify if you...

  • Currently using medications, supplements, or alternative therapies that change energy metabolism.
  • Fasting plasma glucose of 126 mg/dL or higher.
  • Self-reported Type I or Type II diabetes.
  • Significant anemia (hemoglobin < 13.0 g/dL for males or < 11.0 g/dL for females).
  • Currently pregnant, lactating, or pregnant within the last 6 months.
  • History or self-report of gastrointestinal diseases like inflammatory bowel disease, celiac disease, or active gastric ulcers.
  • Evidence of alcohol abuse based on AUDIT questionnaire score.
  • Taking large doses of acetaminophen (> 3 grams daily) and unable to stop 24 hours before and after meal tests.
  • Unable to consume study food due to allergy or intolerance.
  • Any other condition or inability that may jeopardize safety or study adherence as judged by investigators.

AI-Screening

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Trial Site Locations

Total: 1 location

1

NIDDK, Phoenix

Phoenix, Arizona, United States, 85004

Actively Recruiting

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Research Team

S

Susanne M Votruba, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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