Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT (NCT06494449) | Clinical Trial Compass
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 range18 Years – 55 Years
SexALL
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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.
What they're measuring
1
Diet Induced Thermogenesis (DIT) AUC
Timeframe: Pre-consumption (0 minutes) to 300 minutes
Trial details
NCT IDNCT06494449
SponsorMidwest Center for Metabolic and Cardiovascular Research
✕. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
✕. Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
✕. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
✕. Individual has used an alpha-blocker, beta-blocker, or high-dose diuretic within 30 d of visit 1. Unstable use (initiation or change in dose) within 30 d of visit 1 of other antihypertensive medications is also exclusionary.
✕. Unstable use (initiation or change in dose) within 30 d of visit 1 of thyroid hormone replacement medications.
✕. Unstable use (initiation or change in dose) within 30 d of visit 1 of sex hormones for contraception.