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

NCT06223555 | Recruiting

• 2 other identifiers: 10001707001707-DK
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Healthy Volunteer

Keywords

Healthy Volunteer; Obesity; Body Composition; Diet; Mixed Meal Test; Glucose

Outcome Measures

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).

  Baseline, Visit 3/4

Secondary Outcomes (3)

• Body Composition

  Baseline, Visit 3/4

• Resting Metabolic Rate

  Baseline, Visit 3/4

• Lipids

  Baseline, Visit 3/4

Study Arms (2)

1

ACTIVE COMPARATOR

Fixed Mixed Meal Test

Other: Fixed Mixed Meal Test

2

ACTIVE COMPARATOR

Adjusted Mixed Meal Test

Other: Adjusted Mixed Meal Test

Interventions

Fixed Mixed Meal Test OTHER

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

1

Adjusted Mixed Meal Test OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this
• study:
• 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)
• Current pregnancy, pregnancy within the past 6 months or currently lactating
• History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report
• Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults.
• Participants who report taking large doses of acetaminophen (\> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study.
• Inability to consume provided food based on a food allergy or intolerance.

Sponsors & Collaborators

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

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne M Votruba, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne M Votruba, Ph.D.

CONTACT

(301) 827-3521; votrubas@niddk.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: January 25, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)