Trial Outcomes & Findings for Translational Control of Anabolic Resistance in Aging Muscle (NCT NCT03839628)
NCT ID: NCT03839628
Last Updated: 2022-06-22
Results Overview
Change in lean mass
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
baseline and 2-weeks
Results posted on
2022-06-22
Participant Flow
Participant milestones
| Measure |
Reduced Physical Activity
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Reduced Physical Activity
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Translational Control of Anabolic Resistance in Aging Muscle
Baseline characteristics by cohort
| Measure |
Reduced Physical Activity
n=8 Participants
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 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
|
8 participants
n=5 Participants
|
|
HbA1c
|
5.5 % of hemoglobin
STANDARD_DEVIATION 0.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 2-weeksChange in lean mass
Outcome measures
| Measure |
Reduced Physical Activity
n=9 Participants
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
|
|---|---|
|
Lean Mass
|
403 grams
Standard Error 142
|
PRIMARY outcome
Timeframe: baseline and 2-weeksChange in muscle strength
Outcome measures
| Measure |
Reduced Physical Activity
n=9 Participants
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
|
|---|---|
|
Strength
|
-8 percentage of leg strength
Standard Error .1
|
Adverse Events
Reduced Physical Activity
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place