UCSD Q10 and Aging Study

NCT02012322 | Completed

• 1 other identifier: R34AG026338-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Related Symptoms; Age Related Quality of Life Issues

Keywords

Aging; Coenzyme Q10; Q10; Quality of Life; Oxidative Stress; Mitochondrial Function; Cell Energetics; Fatigue; Ubiquinone

Outcome Measures

Primary Outcomes (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)

  2 years

Secondary Outcomes (2)

• Energy (self-reported)

  2 years

• Metabolic and Lipid Panel

  2 years

Study Arms (6)

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

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

100mg/day for three months

Also known as: PharmaNord Myoquinione softgel caplets

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

Placebo DIETARY_SUPPLEMENT

Three month period

Also known as: PharmaNord matched identical softgel placebo

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCSD General Clinical Research Center

La Jolla, California, 92093, United States

Location

Related Links

• Beatrice Golomb MD, PhD CURRICULUM VITAE

MeSH Terms

Conditions

Fatigue

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beatrice A Golomb, M.D., Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 16, 2013
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (1)