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| ID | Type | Description | Link |
|---|---|---|---|
| COPBC | Other Identifier | State of Florida |
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| Name | Class |
|---|---|
| Florida | OTHER |
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This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UA and exercise in paraplegia group | Experimental | Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week. |
|
| UA in tetraplegia group | Experimental | Participants will take UA 4 capsules twice daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursolic Acid | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) | Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry | Baseline, 12 weeks |
| 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 | Baseline, 12 weeks |
| 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. | Baseline, 12 weeks |
| 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). | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Nash, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami - Miami Project to Cure Paralysis | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2025 |
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| Strength Training | Other | 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. |
|
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) | Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry | Posted | Mean | Standard Deviation | grams | Baseline, 12 weeks |
|
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| 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 | Only paraplegia group participated in this outcome measure, per protocol. | Posted | Mean | Standard Deviation | ft-lb | Baseline, 12 weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Only the tetraplegia group participated in this outcome measure, per protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
|
| |||||||||||||||||||||||||||||
| 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). | Only the tetraplegia group participated in this outcome measure, per protocol | Posted | Mean | Standard Deviation | AUC (mg-dL/120 minutes) | Baseline, 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG001 | 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. | 0 | 5 | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| changes in urine | Renal and urinary disorders | Non-systematic Assessment | change in urine color, smell, consistency |
| |
| increased gas or bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Nash, PhD | University of Miami | 305-243-3628 | mnash@med.miami.edu |
| May 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| D010264 | Paraplegia |
| D009133 | Muscular Atrophy |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000097245 | Ursolic Acid |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D012502 | Sapogenins |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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