Age Related SymptomsNCT02012322
UCSD Q10 and Aging Study
A study testing Coenzyme Q10 in people with Age Related Symptoms and Age Related Quality of Life Issues, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Symptoms, Age Related Quality of Life Issues
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD General Clinical Research Center
La Jolla, California, 92093
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Coenzyme Q10, Placebo
- Keywords
- Aging, Coenzyme Q10, Q10, Quality of Life, Oxidative Stress, Mitochondrial Function, Cell Energetics, Fatigue, Ubiquinone
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Also called PharmaNord Myoquinione softgel caplets
100mg/day for three months
Coenzyme Q10Dietary supplement
Also called PharmaNord Myoquinione softgel caplets
300mg/day for three months
PlaceboDietary supplement
Also called PharmaNord matched identical softgel placebo
Three month period
| Study group | Role | What they receive |
|---|---|---|
| Placebo vs. Q10 100mg vs. Q10 300mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Placebo vs. Q10 300mg vs. Q10 100mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 100mg vs. Placebo vs. Q10 300mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 100mg vs. Q10 300mg vs. Placebo | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 300mg vs. Placebo vs. Q10 100mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 300mg vs. Q10 100mg vs. Placebo | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (2)
Energy (self-reported)
Measured: 2 years
Metabolic and Lipid Panel
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Beatrice Golomb, University of California, San Diego
- Investigators
- Beatrice A Golomb, M.D., Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012322
- Sponsor's protocol ID
- R34AG026338-01
- Other IDs
- R34AG026338-01
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coenzyme Q10 and Aging: A Planning Grant
- ClinicalTrials.gov ID
- NCT02012322
- Acronym / sponsor ID
- R34AG026338-01
- Keywords
- Aging, Coenzyme Q10, Q10, Quality of Life, Oxidative Stress, Mitochondrial Function, Cell Energetics, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo vs. Q10 100mg vs. Q10 300mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Placebo vs. Q10 300mg vs. Q10 100mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 100mg vs. Placebo vs. Q10 300mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 100mg vs. Q10 300mg vs. Placebo | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 300mg vs. Placebo vs. Q10 100mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 300mg vs. Q10 100mg vs. Placebo | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: PharmaNord Myoquinione softgel caplets100mg/day for three months | Dietary supplement | Placebo vs. Q10 100mg vs. Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs. Placebo vs. Q10 300mg, Q10 100mg vs. Q10 300mg vs. Placebo, Q10 300mg vs. Placebo vs. Q10 100mg, Q10 300mg vs. Q10 100mg vs. Placebo |
| Coenzyme Q10Also: PharmaNord Myoquinione softgel caplets300mg/day for three months | Dietary supplement | Placebo vs. Q10 100mg vs. Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs. Placebo vs. Q10 300mg, Q10 100mg vs. Q10 300mg vs. Placebo, Q10 300mg vs. Placebo vs. Q10 100mg, Q10 300mg vs. Q10 100mg vs. Placebo |
| PlaceboAlso: PharmaNord matched identical softgel placeboThree month period | Dietary supplement | Placebo vs. Q10 100mg vs. Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs. Placebo vs. Q10 300mg, Q10 100mg vs. Q10 300mg vs. Placebo, Q10 300mg vs. Placebo vs. Q10 100mg, Q10 300mg vs. Q10 100mg vs. Placebo |
Primary outcome
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 secondary outcomes
Energy (self-reported)
Time frame: 2 years
Metabolic and Lipid Panel
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Beatrice Golomb MD, PhD CURRICULUM VITAELink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice A Golomb, M.D., Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Age Related Symptoms and Age Related Quality of Life Issues, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.