NCT05784571: Perform

Assessment of Body Composition and Physical Function

Completed Results posted Last updated 30 July 2024

What this trial tests

trial testing Body Composition Assessment in Body Composition in 40 participants. Completed in 1 June 2023.

Timeline

13 March 2023

Primary endpoint
1 June 2023

1 June 2023

Quick facts

Lead sponsor	Pennington Biomedical Research Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	13 March 2023
Primary completion	1 June 2023
Estimated completion	1 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Body Composition Assessment
• Modified Physical Performance Test
• Hand grip strength
• 6-minute walk test
• Measurement of blood glucose and insulin

Conditions studied

• Body Composition — all drugs for Body Composition →
• Physical Function — all drugs for Physical Function →

Sponsor

Pennington Biomedical Research Center — full company profile →

Who can join

Adults 60 to 80, any sex, with Body Composition or Physical Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fat Mass Primary · One day

Measurement of fat mass

Group	Value	95% CI
Older Adults	44.71	± 13.13

Fat-free Mass Primary · One day

Measurement of fat-free mass

Group	Value	95% CI
Older Adults	55.88	± 12.08

Modified Physical Performance Test Primary · One day

Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome

Group	Value	95% CI
Older Adults	30	± 5.85

Hand Grip Strength Secondary · One day

Assessment of grip strength using a hand dynamometer

Group	Value	95% CI
Older Adults	27.98	± 9.36

6-minute Walk Test Secondary · One day

Test of walking capacity assessed as distance covered in 6 minutes

Group	Value	95% CI
Older Adults	1375.25	± 416.63

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Secondary · One day

Assessment of insulin resistance from blood glucose and insulin. HOMA-IR was calculated as: fasting insulin (μU/mL) × fasting glucose (mmol/L)\]/22.5 Higher scores indicate greater insulin resistance and a worse outcome. There is no theoretical minimum and/or maximum value for HOMA-IR. Studies have suggested a variety of values that vary based on factors such as gender and age. For example, a large epidemiologic study found that HOMA-IR score of 1.85 in women and 2.17 in men indicated insulin resistance. In another study, the HOMA-IR cut point was found to be 2.37 and 2.38 in 70-year old men a

Group	Value	95% CI
Older Adults	4.7	± 3.4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.