NCT06223555 Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
| NCT ID | NCT06223555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 79 participants |
| Start Date | 2024-08-23 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 79 participants in total. It began in 2024-08-23 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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....
Eligibility Criteria
* INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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. * Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. * Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator s and/or team s opinion, jeopardizes the safety of the participant or others or would interfere with adherence to the protocol (such as claustrophobia). Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.
Contact & Investigator
Susanne M Votruba, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT06223555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06223555 currently recruiting?
Yes, NCT06223555 is actively recruiting participants. Contact the research team at votrubas@mail.nih.gov for enrollment information.
Where is the NCT06223555 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT06223555 clinical trial?
NCT06223555 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is Susanne M Votruba, Ph.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 79 participants.
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