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

University of Miami

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Ursolic Acid; Other: Strength Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05776862

COPBC (Other Identifier)

20221142

Details and patient eligibility

About

This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

UA and exercise in paraplegia group

Experimental group

Description:

Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.

Treatment:

Other: Strength Training

Drug: Ursolic Acid

UA in tetraplegia group

Experimental group

Description:

Participants will take UA 4 capsules twice daily for 12 weeks

Treatment:

Drug: Ursolic Acid