Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
NCT ID: NCT05776862
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2023-03-27
2025-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
UA in tetraplegia group
Participants will take UA 4 capsules twice daily for 12 weeks
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Male and female individuals wi4.th chronic (\> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7
Exclusion Criteria
2. Women who are breastfeeding
18 Years
65 Years
ALL
No
Sponsors
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Florida
OTHER
University of Miami
OTHER
Responsible Party
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Mark S. Nash, Ph.D., FACSM
Professor
Principal Investigators
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Mark S Nash, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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COPBC
Identifier Type: OTHER
Identifier Source: secondary_id
20221142
Identifier Type: -
Identifier Source: org_study_id
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