Coenzyme Q10 in Older Athletes Treated With Statin Medications

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: Coenzyme q 10
    • 200 mg of Coenzyme q 10
  • Drug: placebo
    • 1 placebo q d during treatment period

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
  • Active Comparator: Coenzyme Q10
    • 200mg of coenzyme Q10

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Richard Deichmann, MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Richard Deichmann, MD, PI – Ochsner Health System
  • Overall Official(s)
    • Richard Deichmann, MD, Principal Investigator, Ochsner

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