Trial Outcomes & Findings for Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI) (NCT NCT05776862)
NCT ID: NCT05776862
Last Updated: 2025-05-21
Results Overview
Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
UA and Exercise in Paraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
UA and Exercise in Paraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
non-compliance
|
1
|
0
|
Baseline Characteristics
Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Baseline characteristics by cohort
| Measure |
UA and Exercise in Paraplegia Group
n=5 Participants
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
n=5 Participants
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksChanges in muscle mass in grams as measured by Dual X-ray Absorptiometry
Outcome measures
| Measure |
UA and Exercise in Paraplegia Group
n=4 Participants
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
n=4 Participants
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
|
-183.00 grams
Standard Deviation 2642.65
|
1434.00 grams
Standard Deviation 1885.21
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Only paraplegia group participated in this outcome measure, per protocol.
Peak strength (peak torque in ft-lb) of both arms at 90 degrees range of motion will be tested in elbow flexion and extension (at 60 deg/s) on a Biodex dynamometer
Outcome measures
| Measure |
UA and Exercise in Paraplegia Group
n=4 Participants
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Changes in Peak Isokinetic Strength
Involved arm flexion
|
5.58 ft-lb
Standard Deviation 3.55
|
—
|
|
Changes in Peak Isokinetic Strength
Uninvolved arm flexion
|
1.83 ft-lb
Standard Deviation 3.01
|
—
|
|
Changes in Peak Isokinetic Strength
Involved arm extension
|
3.05 ft-lb
Standard Deviation 7.33
|
—
|
|
Changes in Peak Isokinetic Strength
Uninvolved arm extension
|
9.63 ft-lb
Standard Deviation 3.00
|
—
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Only the tetraplegia group participated in this outcome measure, per protocol.
Changes in IR using Homeostatic Model of Assessment (HOMA) v2 model estimates steady state beta cell function and insulin sensitivity as percentages of a normal reference population. The change in resting IR will be measured by (fasting serum glucose\*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity.
Outcome measures
| Measure |
UA and Exercise in Paraplegia Group
n=4 Participants
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Changes in Fasting Insulin Resistance (IR)
|
1.6125 score on a scale
Standard Deviation 2.70
|
—
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Only the tetraplegia group participated in this outcome measure, per protocol
Changes in glucose disposal will be measured by the Oral Glucose Tolerance Test (OGTT) using Trutol glucose solution of 75 grams. The rates of glucose disposal will be defined by the area under the glucose challenge curve (AUC).
Outcome measures
| Measure |
UA and Exercise in Paraplegia Group
n=4 Participants
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Changes in Glucose Disposal
|
930.75 AUC (mg-dL/120 minutes)
Standard Deviation 2327.13
|
—
|
Adverse Events
UA and Exercise in Paraplegia Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
UA in Tetraplegia Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UA and Exercise in Paraplegia Group
n=5 participants at risk
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
n=5 participants at risk
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/5 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
UA and Exercise in Paraplegia Group
n=5 participants at risk
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Strength Training: Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
|
UA in Tetraplegia Group
n=5 participants at risk
Participants will take UA 4 capsules twice daily for 12 weeks
Ursolic Acid: Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
|
|---|---|---|
|
Renal and urinary disorders
changes in urine
|
0.00%
0/5 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
increased gas or bloating
|
40.0%
2/5 • Number of events 2 • 12 weeks
|
0.00%
0/5 • 12 weeks
|
|
Gastrointestinal disorders
diarrhea
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
0.00%
0/5 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
0.00%
0/5 • 12 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/5 • 12 weeks
|
20.0%
1/5 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place