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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
100mg/day for three months
300mg/day for three months
Three month period
UCSD General Clinical Research Center
La Jolla, California, United States
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
Energy (self-reported)
Time frame: 2 years
Metabolic and Lipid Panel
Time frame: 2 years
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