Skip to content

Lean Muscle Function

Obesity and Muscle Function Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01616498
Acronym
LEAN
Enrollment
24
Registered
2012-06-11
Start date
2012-06-30
Completion date
2013-11-30
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Single Muscle Fibers

Brief summary

This pilot study is designed to determine the relationship between intra-myocellular lipids and muscle contractility in fibers from obese and non-obese older adults. Obese participants are being recruited for an on-going weight loss intervention study and this application seeks approval to recruit and enroll a lean comparison group of non-obese older adults. The primary goal of this study is to characterize the contractile properties of single muscle fibers and whole muscle in healthy, non-obese individuals under the same recording conditions the investigators used for the obese population to begin to determine whether fat infiltration accounts for diminished force.

Interventions

None listed

Sponsors

Wake Forest University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Age=65-75 years * BMI=18-24 kg/m2 * No resistance training for past 6 months * Normal cognitive function (MMSE \>24) * No contraindications for participation in weight loss or weight lifting exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year * Able to provide own transportation to study visits * Not involved in any other research study involving strength training or undergoing physical therapy * Not dependent on a cane or walker * Willing to provide informed consent

Exclusion criteria

* Weight loss or gain (±5%) in past 6 months * Body mass \>136 kg (DXA limit) * Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse * Insulin dependent or uncontrolled diabetes (FBG \>140 mg/dL) * Uncontrolled hypertension (BP\>180/100 mmHg) * Abnormal kidney function or liver blood tests * Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>2 mm) on ECG * Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus. These will be reviewed on a case by case basis. * Past or current respiratory disease (requiring steroid treatment or supplemental oxygen) * Past or current clinical diagnoses of neurological or hematological disease * Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox) * Cancer requiring treatment in past 2 years, except non-melanoma skin cancers * Clinically evident edema or anemia

Design outcomes

Primary

MeasureTime frameDescription
Muscle FiberBaselinePrimary Aim: To measure single muscle fiber contractile properties, including specific force, unloaded shortening velocity, and maximum power. We will also measure whole muscle strength and size and fiber fat infiltration. These results will establish a reference database against which data recorded in older obese individuals can be compared. Primary hypothesis: Single muscle fibers will exhibit more force and power in healthy non-obese than obese older adults due to greater intra-myocellular fat infiltration.

Secondary

MeasureTime frameDescription
Muscle StrengthBaselineNon-obese older adults will exhibit greater whole muscle strength (absolute and relative to muscle mass and volume) and power than obese, older adults.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026