Muscle Weakness Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
Verified date | May 2012 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patients = 50 years of age, male or female. - Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study - Self-Described Athletes with any of the following characteristics: - Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment - Regular exercise activity of at least 45 minutes duration 5 times per week Exclusion Criteria: - Use of coenzyme Q10 during the preceding two months. - CPK level at baseline greater than two times the upper limits of normal - LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent - LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ochsner | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Richard Deichmann, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population | The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period. | No |
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