Assessment of Body Composition and Physical Function in Older Adults With Obesity
Conditions: Body Composition, Physical Function
Sponsor: Pennington Biomedical Research Center

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Protocol Title: Assessment of Body Composition and Physical Function in Older Adults 
with Obesity
PI Name: Candida Rebello
Medical Investigator’s Name: Frank Greenway
Protocol Version Date: March 629, 2023
 
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ABSTRACT
Objectives
Sarcopenia, which is the loss of muscle mass and strength or physical function, 
naturally occurs in aging. In sarcopenic obesity, growth of muscle mass and increments 
in strength do not parallel weight gain, and places older adults at increased risk of falls, 
fractures, physical disability, frailty, and mortality from too low muscle strength relative 
to body size.1-4 Our goal is to assess body composition and physical function in older 
adults with obesity.
Design and Method
Aim 1. To assess body composition in older adults (aged 60-80 years) with 
obesity. We will measure body composition using biolelectrical impedance analysis.
Aim 2. To assess insulin resistance in older adults with obesity. We will measure 
homeostatic model assessment of insulin resistance (HOMA-IR) from fasting blood 
glucose and insulin concentrations. 
Aim3. To assess physical function in older adults with obesity. We will measure 
physical function using the hand grip strength, six-minute walk, and Modified Physical 
Performance tests.
This is a pilot study to assess body composition in an older population and there is no 
hypothesis.
Study Design
We propose to conduct a cross-sectional study in 40 adults aged 60 to 80 years with 
obesity. We will measure body composition, insulin resistance, and physical function. 
Subjects who satisfy the eligibility criteria and sign the informed consent will be enrolled. 
Subjects will complete an assessment of body composition by bioelectrical impedance 
analysis, hand grip strength, six-minute walk, and the Modified Physical Performance 
tests. Blood will be drawn for measurement of fasting serum glucose and insulin.
The results of the present study will guide the design and implementation of a clinical 
trial to determine the effect of a diet and exercise intervention on physical performance 
in older adults with sarcopenic obesity. Sarcopenic obesity poses an important health 
challenge given the demographic shift towards an older population. These results will be 
significant, in that they will potentially provide a cost-effective intervention that will 
substantially improve quality of life for the growing number of older individuals with 
obesity who have developed sarcopenia.
 
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Background
Preserving muscle function with a weight loss diet in people with low muscle mass and 
determining whether muscle mass or strength is a valid marker of aging-related 
functional decline are some of the unanswered questions in aging. The proposed study 
will offer insights for refining an operational definition for sarcopenic obesity which 
currently lacks consensus and facilitate the development of an intervention study to 
treat sarcopenic obesity.
Sarcopenic obesity is highly prevalent and seriously debilitating. Epidemiologic 
studies show that the co-existence of sarcopenia (skeletal muscle disorder) and obesity 
increases the risk for cardiovascular disease, type 2 diabetes, and all-cause mortality.5-8 
In the United States (US), the prevalence of sarcopenic obesity in non-institutionalized 
older adults is 18.1% in women and 42.9% in men.9 About a third of community‐dwelling 
older adults fall each year and one in five falls causes broken bones or head injuries.10-
12  Fear of falling is a constant concern about falling, and 20-55% older adults report that 
they restrict their daily activities due to fear of falling.13-20 Limiting activity leads to 
functional decline, decreased quality of life, and institutionalization.17, 21-24  Yet, there are 
no evidence-based therapies that can sustainably treat impaired muscle function in 
patients with obesity.25 It is critical to identify patient-centered strategies for altering the 
disease course in subjects with obesity and muscle dysfunction and improving patient 
outcomes in this vulnerable group.25, 26
Aging and musculoskeletal functional decline. Fat mass increases with age peaking 
at approximately 60 to 75 years of age, whereas muscle mass and strength display an 
accelerated loss.27-31 In addition to muscle loss of 3% to 8% each decade after 30 years 
of age, changes in muscle fiber alter muscle quality.32, 33 For instance, 70-year-olds 
have 25% less fibers in the medial vastus lateralis than 30-year-olds.34 Adults over 70 
years of age lose muscle strength at the extraordinary rate of 22% each year.35 
Selective loss of type II (high force fibers) and declines in protein anabolism are other 
factors that drive aging-related loss of muscle quality.33 In the absence of clarity in 
defining sarcopenic obesity, research that advances our understanding of muscle mass 
and strength in an older population will facilitate the design of intervention studies to 
address sarcopenic obesity
STUDY AIMS
Aim 1. To assess body composition in older adults (aged 60-80 years) with 
obesity. We will measure muscle mass using Bioelectrical Impedance Analysis (BIA).
Aim 2. To assess insulin resistance in older adults with obesity. We will measure 
homeostatic model assessment of insulin resistance (HOMA-IR) from fasting blood 
glucose and insulin concentrations. 
Aim3. To assess physical function in older adults with obesity. We will measure 
physical function using the hand grip strength, six-minute walk, and Modified Physical 
Performance tests.
STUDY DESIGN
This is an observational study and there are no hypotheses.
 
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Inclusion Criteria. For an eligible subject, all of the following criteria must be answered 
"yes": 1) age from 60 to 80 years 2) body mass index (BMI) >30 kg/m2; 3) ability to 
provide written informed consent. 
Exclusion Criteria: For an eligible subject, all of the following criteria must be 
answered "no": 1) self-reported history of diabetes, or cancer within the past five years 
or significant cardiovascular or hepatic or renal disease or dysfunction; and 2) clinically 
significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac 
disease; and 3) Use of pacemakers, implanted cardiac defibrillators, and Class III 
electrical medical devices.
Number of Subjects
We will enroll 40 males and females.
Recruitment 
Subjects will be recruited through the use of printed material, targeted solicitation 
through the Pennington Biomedical Research Center (PBRC) email listserv and social 
media. Participants will complete an online screening and will be contacted by a PBRC 
recruiter for a brief telephone interview to assess eligibility criteria, prior to being 
scheduled for a clinic visit. Subject eligibility criteria will be evaluated at a single 
screening visit. The screening visit will occur in the outpatient clinic, in the morning 
following confirmation of an overnight (at least ten hours) fast. Subjects who provide 
informed consent will proceed with the tests and measurements of the screening visit. 
Subjects who satisfy the eligibility criteria will be enrolled in the study.
Study Timelines
This is an observational study. We expect to complete the study within four months. 
Each eligible subject’s participation in the study will be approximately one day. Primary 
analyses are expected to be completed within a month of the study completion.
Study Endpoints
Eligible subjects will complete tests of body composition and physical function. Our 
primary aim is to assess body composition. The secondary outcomes will be to assess 
insulin resistance and physical function.
CLINIC VISITS
Subjects will complete one screening visit which will be followed by the study 
measurements if the eligibility criteria are met.
Screening and Study Visit (2½ hours)
Subjects will report to Pennington Biomedical in the morning following an overnight fast 
(except for water) that began no later than 10 hours prior to the study appointment. The 
screening visit includes explanation of the study purpose, procedures, and signing of 
the informed consent. If the participant agrees to participate by signing a consent form, 
the following procedures will be performed:
•
Completion of personal and family medical history questionnaire 
•
Measurement of height and metabolic weight.
•
Measurement of vital signs (blood pressure and pulse).
 
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•
Blood collection for completion of serum glucose and insulin measurements. 
•
Bioelectrical Impedance Analysis.
•
Hand grip strength.
•
Six-minute walk test.
•
Modified Physical Performance test.
The schedule of assessments is provided in Table 1.
STUDY PROCEDURES
Bioelectrical Impedance Analysis (BIA) Measurements (about 10 minutes):
Body composition will be measured by BIA.
Modified Physical Performance Test (PPT)
The modified PPT is a performance-based global measure of physical performance that 
evaluates the ability to perform usual daily activities, including both basic activities of 
daily living (ADL) and instrumental activities of daily living (IADL). The PPT involves a 
combination of 9 items that have been developed and tested in both frail and well, 
community-dwelling and institutionalized older and elderly adults and has been used to 
describe and monitor physical performance, degree of disability, loss of independence 
and early mortality.36, 37 This Modified PPT38 includes 6 tasks that are timed: 1) climb a 
flight of 10 stairs, 2) stand up 5 times from a standard chair, 3) walk 50 ft., 4) put on and 
remove a coat, 5) pick up a penny placed 12 inches in front of the foot on the dominant 
side, and 6) lift a standard book to a shelf ~12 in above shoulder height. The other three 
tasks include an evaluation of the ability to climb up and down 4 flights of 10 stairs; 
evaluation of the performance of a 360° turn; and a test of standing balance with feet 
side-by-side, semi-tandem and full-tandem. The score for each item ranges between 0 
and 4, with 36 representing a perfect total score for the test.
Six-minute Walk Test
The six-minute walk test is a self-paced test of walking capacity. Subjects are asked to 
walk as far as possible in six minutes along a flat corridor. The distance in meters is 
recorded. 
Procedure
Screening and Study Visit
Informed Consent
x
Height and Weight
x
Blood Pressure and Pulse
x
Medical History Questionnaire
x
Blood Draw
x
Blood Sample for Archives
x
Bioelectrical Impedance Analysis
x
Hand grip Strength
x
Six-minute Walk Test
x
Modified Physical Performance Test
x
Table 1. Schedule of Assesments
 
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Hand Grip Strength
Hand grip strength is measured using the Jamar Hydraulic Hand Dynamometer (JLW 
Instruments, Chicago, IL) according to the NIH Toolbox® guidelines for assessment of 
hand grip strength. 
Biochemical Assessments 
All measurements will be performed according to standard PBRC procedures for 
drawing blood and the relevant measurement. 
Heart Rate Monitor
Subjects wear a heart rate monitor during tests of physical performance (hand-grip 
strength, PPT, and six-minute walk),
STATISTICAL CONSIDERATIONS
We will calculate the homeostatic model assessment of insulin resistance (HOMA-IR) 
and determine the mean and variability of the results for fat mass, lean mass, skeletal 
muscle index, 39 the hand grip strength, physical performance scores, serum glucose 
and insulin, and HOMA-IR. All analyses will be conducted for the entire sample and 
separated by sex.
POTENTIAL RISKS AND BENEFITS FOR PARTICIPANTS
The study involves the following procedures which may pose a potential risk:
•
Blood Draws. There is the possibility of discomfort, pain, and bruising at the vein on 
the arm where the needle is inserted. There may also be a small risk of bleeding and 
a very small risk of infection at the site of the blood draw. Sterile technique and 
trained personnel minimize these risks.
•
Anthropometric Measurements and Vital Signs. The PBRC outpatient clinic staff 
are trained to perform these procedures in accordance with PBRC standards of 
practice. 
•
Bioelectrical Impedance Analysis. There are no known associated risks involved 
with this measurement.
•
Hand grip strength, six-minute walk, and physical performance tests: There is 
minimal risk of injury during the testing protocols. However, there is a possibility of 
discomfort, muscle fatigue and soreness, shortness of breath, elevated heart rate, 
and dizziness. There is also a risk of falling or losing your balance associated with 
these tests. All tests are conducted in the presence of personnel with extensive 
experience in conducting these tests who will follow at a close distance and be of 
immediate assistance, if required. 
In addition to the potential risks listed above, participants may experience a previously 
unknown risk or side effect.
Potential Benefits 
This is a study to assess muscle mass and physical performance and there are no 
benefits.
 
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Adverse Event and Serious Adverse Event Collection and Reporting
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or 
clinical investigation subject, temporally associated with the study procedures. We 
define AE as any unfavorable and unintended sign (including a clinically significant 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the study procedures. 
We will define a serious adverse event (SAE) as any untoward medical occurrence that 
results in death, is life threatening, requires inpatient hospitalization or prolongation of 
existing hospitalization, results in persistent or significant disability/incapacity or in a 
congenital anomaly. 
Safety will be assessed by recording all adverse events. The study team will inquire 
regarding adverse events while minimizing the chance for bias when detecting 
AEs/SAEs. The study team will employ open-ended and non-leading verbal questioning 
of the subject as the preferred method to inquire about AE occurrence. For example, an 
appropriate question would be: “How are you feeling?”, It is the responsibility of the 
investigator to attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. In such cases, the diagnosis will be documented as the 
AE/SAE and not the individual signs/symptoms. 
Assessment of Intensity. An assessment of intensity for each AE and SAE reported 
during the study will be provided by the investigator and the investigator will assign it to 
one of the following categories:
Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not 
interfering with everyday activities.
Moderate: An event that is sufficiently discomforting to interfere with normal everyday 
activities.
Severe: An event that prevents normal everyday activities.
An AE that is assessed as severe will not be confused with an SAE and both AEs and 
SAEs can be assessed as severe. Severe Adverse Event is a category utilized for rating 
the intensity of an event.
Assessment of Causality. The investigator is obligated to assess the relationship 
between study procedures and the occurrence of each AE/SAE. A "reasonable 
possibility" is meant to convey that there are facts/evidence or arguments to suggest a 
causal relationship, rather than that a relationship cannot be ruled out. The investigator 
will use clinical judgment to determine the relationship. Alternative causes, such as 
concomitant therapy, other risk factors, and the temporal relationship of the event to the 
study treatment will be considered and investigated.
Events meeting the definition of an AE:
•
Any abnormal laboratory test results (clinical chemistry) or other safety assessments 
(e.g., vital signs measurements), including those that worsen from baseline, and felt 
to be clinically significant in the medical and scientific judgment of the investigator.
•
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.
 
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•
New conditions detected or diagnosed after study procedures even though it may 
have been present prior to the start of the study.
•
Signs, symptoms, or the clinical sequelae of a suspected interaction.
Events that do not meet the definition of an AE:
•
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the subject’s condition.
•
Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that 
leads to the procedure is an AE
•
Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
•
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
Reporting of AEs. The reporting of AEs will follow the standards of practice as outlined 
by the Pennington Biomedical Research Center (PBRC) IRB in the ‘Unanticipated 
problems Involving risks to subjects or others’ policy. Once the investigator determines 
that an event meets the definition of an AE that must be reported, the investigator will 
not wait to receive additional information before notifying the responsible parties of the 
event and completing the appropriate forms. An assessment of causality at the time of 
the initial report will be provided. Email transmission of the AE data collection tool will be 
the preferred method to transmit this information followed by notification by telephone 
and/or fax. A copy of the AE report will also be sent to the institution officials. New or 
updated information will be recorded in the originally completed data collection tool. 
We are assessing muscle mass and physical performance using standardized tests and 
the risks are minimal.
The investigators will abide by PBRC policy for ensuring prompt reporting to the IRB, of 
any Unanticipated Problem involving risks to study participants or others (45 CFR 
46.103(b)(5)). Accordingly, events meeting the definition of unanticipated problems will 
be reported within 48 hours, when possible, to avoid potential harm to subjects. PBRC 
Unanticipated Problems reporting procedures require completion and submission to the 
IRB of forms which include detailed information on the event and the actions that will be 
taken to prevent reoccurrence. Reports of Unanticipated Problems, as defined above, 
will be forwarded to OHRP using ohrp@osophs.dhhs.gov, within two weeks of the 
event.
DATA AND SAFETY MONITORING 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a 
daily basis. For each AE, the seriousness, intensity, and relationship to study product 
will be assessed, documented, and supported by an entry in the subject’s medical 
records. During the study, each subject will be carefully monitored for any adverse 
events. After the initial AE/SAE report is completed and sent, the investigator is required 
to follow each subject at subsequent contacts. 
 
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PROTECTION AGAINST STUDY RISKS
Informed Consent Process. 
The subjects will be interviewed in the privacy of an exam room and their records will be 
protected by a secure medical records area and a password-protected electronic 
database monitored by the Pennington Research Computing group. Subjects will be 
asked to sign a written consent after reading it, having it reviewed with them by the 
study staff and having all their questions answered.  The consent conversation will be 
conducted in the privacy of an exam room and the subject will be allowed to take the 
consent home to discuss their decision with their family or counselor, if desired. Written 
informed consent will be obtained in the outpatient research clinic by the coordinators 
and one of the physicians will be available to answer questions if needed. A waiting 
period will be allowed, if desired by the participant. The coordinators and investigators 
will be available for questions throughout the study.
Minimizing risks
Study procedures will be conducted by trained staff in accordance with PBRC outpatient 
clinic standards of practice and with the subjects’ informed consent. Continuous 
monitoring by the PI and/or the medical investigator of the study will minimize all 
potential risks and discomforts. Research participants will be immediately withdrawn 
from the study upon evidence of any significant adverse event if the investigative team 
deems that the safety of the participant is in jeopardy.
DATA COLLECTION AND QUALITY ASSUARANCE
Privacy
The subjects will be interviewed in the privacy of an exam room and their records will be 
protected by a secure medical records area and a password-protected electronic 
database monitored by the Pennington Research Computing group. Subjects will be 
asked to sign a written consent after reading it, having it reviewed with them by the 
study staff and having all their questions answered.  The consent conversation will be 
conducted in the privacy of an exam room and the subject will be allowed to take the 
consent home to discuss their decision with their family or counselor, if desired. Study 
procedures will be conducted by trained staff in accordance with PBRC outpatient clinic 
standards of practice and with the subjects informed consent. Confidential subject 
information including medical records and test results will be available only to persons 
authorized by the Pennington. Information collected from subjects will be the minimum 
amount of data necessary to accomplish the research purposes.
Data and Specimen Management
Study participants will be assigned unique subject identification (ID) numbers. Study 
subject ID numbers will be used on all data collection instruments, to include 
questionnaires, data collection forms, and computer records. The forms used for data 
collection will be the standard forms used in PBRC studies. A master list linking the 
participants’ names and ID numbers will be kept in a password-protected computer file 
with access restricted to the PI and co-PI. Data collection forms will be kept secure, or 
password-protected if computerized, and under the control of the PI, co-PI/medical 
investigator. Only personnel assigned to the research study by the PI will have access 
to the data. Hard-copy data records will be stored for a minimum of 3 years.
 
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The PBRC has a fully integrated, campus-wide, automated data management system. 
All data are entered into a central database using existing methodology that has been 
fully validated and undergoes continuous quality assurance by the PBRC Research 
Computing Core. All data are backed up daily, and the Research Computing Core at the 
PBRC oversees all data management. The research team has extensive experience 
using the procedures and methods required to conduct this study. Standard operating 
procedures in place throughout the units at Pennington Biomedical will be utilized for 
repeatable, valid data collection and quality.  
In accordance with the standards of practice followed by the Clinical Chemistry core, 
blood samples will be stored frozen at PBRC until analysis can be completed. 
Protection of Confidentiality 
The only people who will know that these patients are research participants are 
members of the research team.  No information about them, or provided by them during 
the research, will be disclosed to others without their written permission, except if it is 
necessary to protect their rights or welfare (for example, in case of injury or emergency 
care), or if it is required by law.  When the results of the research are published or 
discussed in conferences, no information will be included that would reveal the identity 
of these patients.  All data will be kept in locked files, and subjects will be identified by 
codes when the data gathered in this procedure are presented or published.  
WITHDRAWAL OF SUBJECTS
It is our desire to analyze the results of all participants who were enrolled in the study. In 
accordance with the declaration of Helsinki/Tokyo/Venice/Hong Kong, participants have 
the right to withdraw from the program at any time for any reason. The investigator also 
has the right to withdraw participants from the program treatments in the event of inter-
current illness, adverse experience, treatment failure, protocol violation, or other 
reasons. Should a participant decide to withdraw from the study, all efforts will be made 
to complete observations as thoroughly as possible. 
PAYMENT FOR PARTICIPATION 
At the completion of all study visits and procedures, participants will be paid $75 for the 
time spent in the clinic. This compensation is in line with all the other studies conducted 
at the Pennington Biomedical Research Center. There is no compensation for the 
screening visit.
EMERGENCY CARE AND COMPENSATION FOR RESEARCH-RELATED INJURY
No form of compensation for medical treatment is available from the Pennington 
Biomedical Research Center.  In the event of injury or medical illness resulting from the 
research procedures the research volunteer (from any group) will be referred to their 
physician/surgeon or a treatment facility.  The Pennington Biomedical Research Center 
is a research facility and provides medical treatment only as part of research protocols.  
Should a volunteer require medical treatments, community physicians and hospitals 
must provide them to him/her.  
 
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SHARING OF RESULTS WITH SUBJECTS 
At the end of the study, a manuscript will be prepared for submission to a peer-reviewed 
journal. A summary of the results will be posted on ClinicalTrials.gov which subjects 
may access. 
RESOURCES AVAILABLE 
The outpatient research units are well equipped and staffed to carry out the 
requirements of this study and appropriate standards of practice are in place to ensure 
appropriate research procedures.
ECONOMIC BURDEN TO SUBJECTS 
There are no costs for which the subjects will be responsible. 
CONSENT PROCESS 
Written informed consent will be obtained in the outpatient research clinic by the 
coordinators and one of the physicians will be available to answer questions if needed. 
A waiting period will be allowed, if desired by the participant. The coordinators and 
investigators will be available for questions throughout the study.
 
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