Perform: Assessment of Body Composition and Physical Function

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05784571
Collaborator
(none)
40
1
5.7
7.1

Study Details

Study Description

Brief Summary

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. The goal of the study is to assess body composition and physical function in older adults with obesity.

Condition or Disease Intervention/Treatment Phase
  • Other: Body Composition Assessment
  • Other: Modified Physical Performance Test
  • Other: Hand grip strength
  • Other: 6-minute walk test
  • Procedure: Measurement of blood glucose and insulin

Detailed Description

This is a cross-sectional study in 40 adults aged 60 to 80 years with obesity. Body composition, physical function, and insulin resistance will be measured. 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 and tests of physical performance. Blood will be drawn for measurement of fasting glucose and insulin.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Body Composition and Physical Function in Older Adults With Obesity
Actual Study Start Date :
Mar 13, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Older Adults

Adults 60-80 years of age with body mass index > 30kg/m2

Other: Body Composition Assessment
Assessment of body composition using bioelectrical impedance analysis.

Other: Modified Physical Performance Test
A test of physical functioning

Other: Hand grip strength
A test of hand grip strength using a hand dynamometer.

Other: 6-minute walk test
Self-paced test of walking capacity.

Procedure: Measurement of blood glucose and insulin
Blood will be drawn for measurement of glucose and insulin.

Outcome Measures

Primary Outcome Measures

  1. Fat mass [One day]

    Measurement of fat mass

  2. Fat-free mass [One day]

    Measurement of fat-free mass

  3. Modified Physical Performance Test [One day]

    Assessment of physical function

Secondary Outcome Measures

  1. Hand grip strength [One day]

    Assessment of grip strength using a hand dynamometer

  2. 6-minute walk test [One day]

    Test of walking capacity assessed as distance covered in 6 minutes

  3. Insulin resistance [One day]

    Assessment of insulin resistance from blood glucose and insulin

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Body mass index > 30kg/m2

  • Age 60 - 80 years

Exclusion Criteria:
  • self-reported history of diabetes, or cancer or significant cardiovascular or hepatic or renal disease or dysfunction.

  • clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

Sponsors and Collaborators

  • Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Candida J Rebello, Ph.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Candida Rebello, Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT05784571
Other Study ID Numbers:
  • PBRC 2023-001
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2023