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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2025-01-29

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Ursolic Acid

Intervention Type 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.

Strength Training

Intervention Type 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 in tetraplegia group

Participants will take UA 4 capsules twice daily for 12 weeks

Group Type EXPERIMENTAL

Ursolic Acid

Intervention Type 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.

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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Mark S. Nash, Ph.D., FACSM

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

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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