CompletedNot Applicable

Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT

United States36 participantsStarted 2024-08-08

Plain-language summary

The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female 18 to 55 years of age, inclusive. There will be approximately equal numbers of men and women within the groups with overweight/obesity and normal weight.
. Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
. Individual has a REE (measured at the screening visit using indirect calorimetry) between 1,250 and 2,250 kcals/d.
. For premenopausal women, individual has a history of regular menstrual cycles (21-35 d per cycle) for at least 3 months prior to visit 1.
. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
. Individual is willing and able to undergo the scheduled study procedures.
. Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

. Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine (i.e., diabetes), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diet Induced Thermogenesis (DIT) AUC

Timeframe: Pre-consumption (0 minutes) to 300 minutes

Trial details

NCT IDNCT06494449

SponsorMidwest Center for Metabolic and Cardiovascular Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-27

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