A Randomized, Crossover Trial to Assess the Effects of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on Diet Induced Thermogenesis in Adults With Overweight or Obesity

Midwest Center for Metabolic and Cardiovascular Research1 site in 1 country36 target enrollmentAugust 8, 2024

ConditionsHealthy Overweight and Obesity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Midwest Center for Metabolic and Cardiovascular Research
Enrollment: 36
Locations: 1
Primary Endpoint: Diet Induced Thermogenesis (DIT) AUC
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 8, 2024

End Date

November 27, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Midwest Center for Metabolic and Cardiovascular Research

Responsible Party

Sponsor

Eligibility Criteria

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
•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.
•Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit
•Use of hemp/marijuana products within 12 months of visit
•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
•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.