Lean Muscle Function (LEAN)

This study has been completed.
Information provided by (Responsible Party):
Barbara Nicklas, PhD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
First received: June 7, 2012
Last updated: November 15, 2013
Last verified: November 2013
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.

Single Muscle Fibers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obesity and Muscle Function Pilot Study

Resource links provided by NLM:

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Muscle Fiber [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Primary 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 Outcome Measures:
  • Muscle Strength [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Non-obese older adults will exhibit greater whole muscle strength (absolute and relative to muscle mass and volume) and power than obese, older adults.

Biospecimen Retention:   Samples Without DNA
serum and plasma to be retained

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Comparison data from this lean cohort will be compared to the obese older adults are already being collected in an R01-funded study (Improving Muscle for Functional Independence Trial; IRB00009098; NCT01049698)


Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
20 sedentary, normal-weight (BMI= 18-24 kg/m2) older (65-75 yrs) men and women (n=10 each)

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01616498

United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Principal Investigator: Barbara Nicklas, PhD Wake Forest School of Medicine
  More Information

Responsible Party: Barbara Nicklas, PhD, Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01616498     History of Changes
Other Study ID Numbers: IRB00019632 
Study First Received: June 7, 2012
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 30, 2016