N/A
N=22
Regulation of Muscle Protein Phenotype in Humans With Obesity
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04700800 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Whole-Muscle Protein Synthesis — 0.004; 0.015 %/hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole-Muscle Protein Synthesis |
0.004; 0.015 | — |
| PRIMARY Synthesis Rates of the Three Myosin Heavy Chain Isoforms (MHC I, MHC IIa, and MHC IIx) |
0.005; 0.006; 0.004; 0.005 | — |
| PRIMARY Messenger RNA (mRNA) Expression of Three Myosin Heavy Chain Isoforms (MHC I, MHC IIa, and MHC IIx) |
1.1; 1.0; 0.5; 0.6 | — |
Summary
A hallmark of muscle changes in obesity is an altered muscle fiber type profile, characterized by a reduced proportion of Type I fibers - a shift associated with adverse obesity-related health outcomes. This alteration can be linked to changes in the expression of myosin heavy chain (MHC) protein isoforms in the skeletal muscle of individuals with obesity. The investigators aim to modulate the metabolism of muscle MHC isoforms to uncover the biological mechanisms underlying this disrupted expression pattern in muscle of humans with obesity.
Eligibility Criteria
Inclusion Criteria
- ability to sign informed consent form
- body mass index (BMI), 18-26 kg/m2 (lean subjects), 32-50 kg/m2 (subjects with obesity)
Exclusion Criteria
- prescription or over-the-counter medication
- supplements known to affect protein metabolism (i.e., amino acids, protein, omega-3 fatty acids)
- diabetes
- acute illness
- liver disease
- uncontrolled metabolic disease, including renal disease
- heart disease related to atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure or ECG documented abnormalities
- low hemoglobin or hematocrit
- use of anabolic steroids or corticosteroids (within 3 months)
- not classified as inactive/sedentary based on the Stanford Brief Activity Survey and accelerometry data
- participation in a weight-loss regimen
- extreme dietary practices (i.e., vegan, vegetarian)
- smoking
- pregnancy
- gastro-intestinal surgery
- any other condition or event considered exclusionary by the PI and the study physician.
Data sourced from ClinicalTrials.gov (NCT04700800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.