Trial Outcomes & Findings for Assessment of Body Composition and Physical Function (NCT NCT05784571)
NCT ID: NCT05784571
Last Updated: 2024-07-30
Results Overview
Measurement of fat mass
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
One day
Results posted on
2024-07-30
Participant Flow
Participant milestones
| Measure |
Older Adults
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Body Composition and Physical Function
Baseline characteristics by cohort
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Older adults
Measurement of fat mass
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Fat Mass
|
44.71 Kg
Standard Deviation 13.13
|
PRIMARY outcome
Timeframe: One dayPopulation: Older adults
Measurement of fat-free mass
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Fat-free Mass
|
55.88 Kg
Standard Deviation 12.08
|
PRIMARY outcome
Timeframe: One dayPopulation: Older adults
Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Modified Physical Performance Test
|
30 score on a scale
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: One dayPopulation: Average of the left- and right-hand grip strength measurement.
Assessment of grip strength using a hand dynamometer
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Hand Grip Strength
|
27.98 kilograms
Standard Deviation 9.36
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SECONDARY outcome
Timeframe: One dayTest of walking capacity assessed as distance covered in 6 minutes
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
6-minute Walk Test
|
1375.25 Feet
Standard Deviation 416.63
|
SECONDARY outcome
Timeframe: One dayAssessment 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 and women respectively (see references).
Outcome measures
| Measure |
Older Adults
n=40 Participants
Adults 60-80 years of age with body mass index \> 30kg/m2
Body Composition Assessment: Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test: A test of physical functioning
Hand grip strength: A test of hand grip strength using a hand dynamometer.
6-minute walk test: Self-paced test of walking capacity.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin.
|
|---|---|
|
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
4.7 Score on a scale
Standard Deviation 3.4
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Adverse Events
Older Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Candida Rebello
Pennington Biomedical Research Center, Baton Rouge, LA
Phone: 2257633159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place