UCSD Q10 and Aging Study

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.

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)