Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injuries, Tetraplegia, Paraplegia, Muscle Loss, Atrophy, Muscular, Insulin Resistance

Intervention / Treatment
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* Drug: Ursolic Acid
* Other: Strength Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8 Male and female individuals wi4.th chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7 Exclusion Criteria: Pregnant or planning to become pregnant Women who are breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UA and exercise in paraplegia group<br>Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week. | Drug: Ursolic Acid<br>* 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.<br>Other: Strength Training<br>* 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.<br>|
| Experimental: UA in tetraplegia group<br>Participants will take UA 4 capsules twice daily for 12 weeks | Drug: Ursolic Acid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass using Dual X-ray Absorptiometry (DXA) | Changes in muscle mass as measured by Dual X-ray Absorptiometry | Baseline, 12 weeks | 
| Changes in muscle mass using Computed Tomography (CT) scans | Changes in muscle mass as measured by CT scans | Baseline, 12 weeks | 
| Changes in peak isokinetic strength | Peak strength of both arms at 90 degrees of flexion will be tested in elbow flexion and extension 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 |