UCSD Q10 and Aging Study (NCT02012322) | Clinical Trial Compass
CompletedNot Applicable
UCSD Q10 and Aging Study
United States44 participantsStarted 2008-11
Plain-language summary
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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)