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

NCT05776862 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 20221142COPBC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Ursolic Acid; Other: Strength Training

UA in tetraplegia group

EXPERIMENTAL

Participants will take UA 4 capsules twice daily for 12 weeks

Drug: Ursolic Acid

Interventions

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.

UA and exercise in paraplegia group; UA in tetraplegia group

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.

UA and exercise in paraplegia group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or planning to become pregnant
• Women who are breastfeeding

Sponsors & Collaborators

• University of Miami: lead
• Florida: collaborator

Study Sites (1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paraplegia; Muscular Atrophy; Insulin Resistance

Interventions

Ursolic Acid; Resistance Training

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Sapogenins; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Mark Nash, PhD
• Organization: University of Miami

mnash@med.miami.edu

305-243-3628

Study Officials

• Mark S Nash, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 27, 2023
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)