UCSD Q10 and Aging Study

December 17, 2013 updated by: Beatrice Golomb, University of California, San Diego

Coenzyme Q10 and Aging: A Planning Grant

Goal: The investigators propose to test the feasibility of giving the supplement coenzyme Q10 (Q10) improves symptoms and subjective health in an aging population.

Rationale: Direct empirical evidence has supported benefit of Q10 to many symptoms such as fatigue, muscle pain, and cognition. In addition, Q10 has also been reported to benefit other symptoms including headaches, sleep disturbances, and breathing problems. This provides a strong rationale for testing whether Q10 will have similar benefit to these symptoms in an aging population.

Method: 44 aging subjects will participate. The design is a 9 month, randomized, double-blind, placebo-controlled crossover study. Each subject will be "crossed over" between high dose Q10 (300mg), low dose Q10 (100mg), and placebo, receiving each agent for 3 month periods. Neither subjects nor investigators will know which substance each subject is receiving in which phase. Subjects will be randomly assigned to one of six arms.

Assessments: Assessments will include feasibility of study, subjective quality of life, energy, and metabolic and lipid panels. Analyses will show whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses; and whether people with certain symptoms or characteristics get more benefit than people with other symptoms or characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Goal: To determine feasibility of a double-blind placebo-controlled crossover study to test whether coenzyme Q10 (Q10) administration reduces symptoms and improve subjective health in an aging population.

Rationale: In a number of settings, studies have reported benefits of Q10 to fatigue, muscle pain, and cognition. Additionally Q10 defends against mechanisms that may play a role in health problems in aging populations. For these reasons, a study evaluating benefits by Q10 to symptoms and quality of life in an aging population is merited.

Subjects: 44 subjects ages 55 and older.

Design: 9 month, randomized, placebo-controlled, double-blind crossover study.

Analyses: Nonparametric and secondarily parametric analyses will compare effects of Q10 vs placebo; and of higher dose vs lower dose Q10 on primary and secondary endpoints. Possible effect modification (differential benefit) based on factors such as oxidative state and Q10 serum concentration will be explored through regression analysis.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD General Clinical Research Center

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

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females >55 years with a minimum of 40% females
  • Willing to fast for 8 hrs prior to blood draw
  • Must be able to complete survey instruments or assessments
  • Must be independent living
  • Must be community living
  • Willing to defer participation in other clinical trials till after completion of study participation.
  • Agree to abstain from other Q10-containing products for the duration of participation

Exclusion Criteria:

  • Women who are pre-menopausal or have the capability to conceive children
  • Diagnosed with HIV
  • Diagnosed with cancer (except non-melanoma skin cancer)
  • Diagnosed with NYHA Stage 3 or 4 congestive heart failure
  • Is currently taking coumadin
  • Cannot commit to continued participation for a minimum of 1 year
  • Have taken Q10 including dermal preparations in the last three months
  • Due to the very small number of subjects, special classes (including prisoners, institutionalized individuals, or other who may be considered vulnerable populations)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo vs. Q10 100mg vs. Q10 300mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Placebo vs. Q10 300mg vs. Q10 100mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 100mg vs. Placebo vs. Q10 300mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 100mg vs. Q10 300mg vs. Placebo
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 300mg vs. Placebo vs. Q10 100mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 300mg vs. Q10 100mg vs. Placebo
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility and Acceptability (e.g., duration of study, study visits, comprehension of the quality of life questionnaires, reliability of the cognitive function measures, tolerance of study drug)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Energy (self-reported)
Time Frame: 2 years
2 years
Metabolic and Lipid Panel
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34AG026338-01 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Age Related Symptoms

Clinical Trials on Coenzyme Q10

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe