Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2008-11-30
2009-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo vs. Q10 100mg vs. Q10 300mg
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Placebo vs. Q10 300mg vs. Q10 100mg
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Q10 100mg vs. Placebo vs. Q10 300mg
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Q10 100mg vs. Q10 300mg vs. Placebo
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Q10 300mg vs. Placebo vs. Q10 100mg
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Q10 300mg vs. Q10 100mg vs. Placebo
Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Interventions
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Coenzyme Q10
100mg/day for three months
Coenzyme Q10
300mg/day for three months
Placebo
Three month period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Diego
OTHER
Responsible Party
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Beatrice Golomb
Professor of Medicine
Principal Investigators
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Beatrice A Golomb, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UCSD General Clinical Research Center
La Jolla, California, United States
Countries
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Related Links
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Beatrice Golomb MD, PhD CURRICULUM VITAE