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

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

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

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance; Spinal Cord Injuries; Tetraplegia; Muscle Loss; Paraplegia; Atrophy, Muscular
• Intervention / Treatment: Drug: Ursolic Acid; Other: Strength Training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Patricia Graham, MS; Phone Number: 3052435119; Email: pgraham1@med.miami.edu
• Study Contact Backup: Name: Mark S Nash, PhD; Phone Number: 305.243.3628; Email: mnash@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami - Miami Project to Cure Paralysis
      • Contact: Mark S Nash, PhD; Phone Number: 305-243-3628; Email: mnash@med.miami.edu
      • Contact: Patricia Graham, MS, CCRC; Phone Number: 305-243-5119; Email: pgraham1@med.miami.edu
      • Principal Investigator: Mark S Nash, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida
• Investigators: Principal Investigator: Mark S Nash, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Trauma, Nervous System; Spinal Cord Diseases; Hyperinsulinism; Atrophy; Paralysis; Wounds and Injuries; Insulin Resistance; Muscular Atrophy; Spinal Cord Injuries; Quadriplegia; Paraplegia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Ursolic Acid
• Other Study ID Numbers: 20221142; COPBC (Other Identifier: State of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes