Atrophy, Muscular, Insulin Resistance, Muscle Loss, Paraplegia, Spinal Cord Injuries, Tetraplegia
Conditions
Brief summary
This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.
Interventions
DRUGUrsolic 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.
OTHERStrength 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.
Sponsors
Florida
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female individuals with paraplegia having chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8 2. Male and female individuals wi4.th chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7
Exclusion criteria
1. Pregnant or planning to become pregnant 2. Women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) | Baseline, 12 weeks | Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry |
| Changes in Peak Isokinetic Strength | Baseline, 12 weeks | 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 |
| Changes in Fasting Insulin Resistance (IR) | Baseline, 12 weeks | 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. |
| Changes in Glucose Disposal | Baseline, 12 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | non-compliance | 1 | 0 |
Baseline characteristics
| Characteristic | Total | UA and Exercise in Paraplegia Group | UA in Tetraplegia Group |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 11.6 | 37.2 years STANDARD_DEVIATION 14.8 | 37.8 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 1 / 5 |
Outcome results
Primary
Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UA and Exercise in Paraplegia Group | Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) | -183.00 grams | Standard Deviation 2642.65 |
| UA in Tetraplegia Group | Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) | 1434.00 grams | Standard Deviation 1885.21 |
Primary
Changes in Fasting Insulin Resistance (IR)
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.
Time frame: Baseline, 12 weeks
Population: Only the tetraplegia group participated in this outcome measure, per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UA and Exercise in Paraplegia Group | Changes in Fasting Insulin Resistance (IR) | 1.6125 score on a scale | Standard Deviation 2.7 |
Primary
Changes in Glucose Disposal
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).
Time frame: Baseline, 12 weeks
Population: Only the tetraplegia group participated in this outcome measure, per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UA and Exercise in Paraplegia Group | Changes in Glucose Disposal | 930.75 AUC (mg-dL/120 minutes) | Standard Deviation 2327.13 |
Primary
Changes in Peak Isokinetic Strength
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
Time frame: Baseline, 12 weeks
Population: Only paraplegia group participated in this outcome measure, per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UA and Exercise in Paraplegia Group | Changes in Peak Isokinetic Strength | Involved arm flexion | 5.58 ft-lb | Standard Deviation 3.55 |
| UA and Exercise in Paraplegia Group | Changes in Peak Isokinetic Strength | Uninvolved arm flexion | 1.83 ft-lb | Standard Deviation 3.01 |
| UA and Exercise in Paraplegia Group | Changes in Peak Isokinetic Strength | Involved arm extension | 3.05 ft-lb | Standard Deviation 7.33 |
| UA and Exercise in Paraplegia Group | Changes in Peak Isokinetic Strength | Uninvolved arm extension | 9.63 ft-lb | Standard Deviation 3 |