Spinal Cord InjuriesPhase 2NCT05776862

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

A Phase 2 study testing Ursolic Acid and Strength Training in people with Spinal Cord Injuries and Tetraplegia, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injuries, Tetraplegia, Paraplegia
What is being tested?: Ursolic Acid and Strength Training
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2023to 29 Jan 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant or planning to become pregnant
Women who are breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136

Other trials in United States

About this study

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)

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
Being tested: Ursolic Acid, Strength Training
Medical subject headings: Spinal Cord Injuries, Quadriplegia, Paraplegia, Muscular Atrophy, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ursolic AcidDrug
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.
Strength TrainingOther
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.

Study groups in NCT05776862
Study group	Role	What they receive
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. Receives: Drug: Ursolic Acid; Other: Strength Training
UA in tetraplegia group	Experimental	Participants will take UA 4 capsules twice daily for 12 weeks Receives: Drug: Ursolic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry
Measured: 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
Measured: 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.
Measured: 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).
Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202329 Jan 2025

First posted20 Mar 2023
Study start27 Mar 2023
Primary completion29 Jan 2025
Study completion29 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05776862
Sponsor's protocol ID: 20221142
Other IDs: COPBC
Status last verified: May 2025
First submitted: 7 Mar 2023
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05776862
Acronym / sponsor ID: 20221142
Conditions: Spinal Cord Injuries, Tetraplegia, Paraplegia, Muscle Loss, Atrophy, Muscular, Insulin Resistance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Florida
Study start: 27 Mar 2023 (actual)
Primary completion: 29 Jan 2025 (actual)
Study completion: 29 Jan 2025 (actual)
First posted: 20 Mar 2023 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
UA and exercise in paraplegia group	Experimental	Drug: Ursolic Acid, Other: Strength TrainingParticipants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
UA in tetraplegia group	Experimental	Drug: Ursolic AcidParticipants will take UA 4 capsules twice daily for 12 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

Pregnant or planning to become pregnant
Women who are breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ursolic AcidSubjects 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.	Drug	UA and exercise in paraplegia group, UA in tetraplegia group
Strength TrainingSubjects 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.	Other	UA and exercise in paraplegia group

Primary outcome

Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
Time frame: Baseline, 12 weeks
Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry
Changes in Peak Isokinetic Strength
Time frame: 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)
Time frame: 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
Time frame: 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).

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UA and Exercise in Paraplegia Group	5	4
UA in Tetraplegia Group	5	4

Primary outcome: Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: grams

Measure	UA and Exercise in Paraplegia Group n = 4	UA in Tetraplegia Group n = 4
Value	-183.00 (2642.65)	1434.00 (1885.21)

Primary outcome: Changes in Peak Isokinetic Strength

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: ft-lb

Measure	UA and Exercise in Paraplegia Group n = 4
Involved arm flexion	5.58 (3.55)
Uninvolved arm flexion	1.83 (3.01)
Involved arm extension	3.05 (7.33)
Uninvolved arm extension	9.63 (3.00)

Population analysed: Only paraplegia group participated in this outcome measure, per protocol.

Primary outcome: Changes in Fasting Insulin Resistance (IR)

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	UA in Tetraplegia Group n = 4
Value	1.6125 (2.70)

Population analysed: Only the tetraplegia group participated in this outcome measure, per protocol.

Primary outcome: Changes in Glucose Disposal

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: AUC (mg-dL/120 minutes)

Measure	UA in Tetraplegia Group n = 4
Value	930.75 (2327.13)

Population analysed: Only the tetraplegia group participated in this outcome measure, per protocol

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UA and Exercise in Paraplegia Group	0 of 5 (0%)	3 of 5 (60%)	0 of 5
UA in Tetraplegia Group	1 of 5 (20%)	2 of 5 (40%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark S Nash, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ursolic Acid and Strength Training in people with Spinal Cord Injuries and Tetraplegia, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA) (time frame: Baseline, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.