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

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05776862

Collaborator

Florida (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Tetraplegia Paraplegia Muscle Loss Atrophy, Muscular Insulin Resistance	Drug: Ursolic Acid Other: Strength Training	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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. Other: 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.
Experimental: UA in tetraplegia group Participants will take UA 4 capsules twice daily for 12 weeks	Drug: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Other: 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.

Experimental: UA in tetraplegia group

Participants will take UA 4 capsules twice daily for 12 weeks

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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