Coenzyme Q10 in Older Athletes Treated With Statin Medications

May 1, 2012 updated by: Richard Deichmann, MD

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
1 placebo q d during treatment period
ACTIVE_COMPARATOR: Coenzyme Q10
200mg of coenzyme Q10
200 mg of Coenzyme q 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Deichmann, MD, Ochsner

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (ESTIMATE)

December 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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