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

Phase 2

Completed

• Conditions: Tetraplegia; Muscle Loss; Insulin Resistance; Paraplegia; Atrophy, Muscular; Spinal Cord Injuries
• Interventions: Drug: Ursolic Acid; Other: Strength Training

• Registration Number: NCT05776862
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-03-27
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Status Verified: 2025-05
• Results First Submitted: 2025-05-02
• Results First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Results First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UA and exercise in paraplegia group	Strength Training	Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
UA and exercise in paraplegia group	Ursolic Acid	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	Ursolic Acid	Participants will take UA 4 capsules twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Miami - Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States