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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05776862
Other study ID # 20221142
Secondary ID COPBC
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 27, 2023
Est. completion date May 1, 2025

Study information

Verified date April 2024
Source University of Miami
Contact Patricia Graham, MS
Phone 3052435119
Email pgraham1@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of Miami - Miami Project to Cure Paralysis Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscle mass using Dual X-ray Absorptiometry (DXA) Changes in muscle mass as measured by Dual X-ray Absorptiometry Baseline, 12 weeks
Primary Changes in muscle mass using Computed Tomography (CT) scans Changes in muscle mass as measured by CT scans Baseline, 12 weeks
Primary 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
Primary 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
Primary 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
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