Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Lean Muscle Function (LEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616498
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Barbara Nicklas, PhD, Wake Forest University Health Sciences

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.

Condition or disease
Single Muscle Fibers

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Obesity and Muscle Function Pilot Study
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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)

Primary Outcome Measures :
  1. Muscle Fiber [ Time Frame: Baseline ]

    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 :
  1. Muscle Strength [ Time Frame: Baseline ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616498

Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Layout table for investigator information
Principal Investigator: Barbara Nicklas, PhD Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Barbara Nicklas, PhD, Professor, Wake Forest University Health Sciences Identifier: NCT01616498    
Other Study ID Numbers: IRB00019632
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.