Coenzyme Q10 for Gulf War Syndrome

Overseen By Janis B Ritchie, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Must not be taking: Coumadin/warfarin

Disqualifiers: Other clinical trials, Covid, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

192 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to delay starting any new treatments or supplements during the study.

What data supports the effectiveness of the drug Bio-Quinone Active CoQ10 Gold 100mg for Gulf War Syndrome?

A study found that Coenzyme Q10 at 100 mg per day improved physical function and symptoms in male Gulf War veterans, showing significant benefits compared to a placebo. This suggests that CoQ10 may help with some symptoms of Gulf War Syndrome. ^{1 2 3 4 5}

Is Coenzyme Q10 safe for human use?

Coenzyme Q10 is generally considered safe for human use, with studies showing no serious adverse effects even at high doses up to 1200 mg per day. Some mild gastrointestinal issues like nausea have been reported, but these are not linked to the dose. Overall, CoQ10 has a strong safety profile based on both animal and human studies. ^{2 6 7 8 9}

How does the drug Coenzyme Q10 differ from other treatments for Gulf War Syndrome?

Coenzyme Q10 is unique because it is a natural antioxidant that supports energy production in cells, which may help alleviate symptoms related to mitochondrial dysfunction. Unlike other treatments, it is taken orally and can maintain high blood levels over time, potentially offering sustained benefits without significant side effects. ^{3 5 10 11 12}

Research Team

Beatrice A Golomb, MD, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for veterans who have Gulf War illness, which may include conditions like mitochondrial disease or myopathy. Participants should not have other serious medical issues that could interfere with the study.

Inclusion Criteria

Does not have a disqualifying condition

Health prior to the Gulf War rated as 'very good' or 'excellent' (to exclude persons who may have had other health conditions with different mechanisms as the cause of their symptoms)

Adequate internet access to allow ZoomPro visit participation and remote survey completion

Exclusion Criteria

Unable to participate for the required duration of the study

I am currently experiencing side effects from a recent medication or illness.

Participating in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CoQ10 or placebo for either 3.5 months or 7 months, with crossover from placebo to active treatment at 3.5 months

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bio-Quinone Active CoQ10 Gold 100mg

Trial Overview The study is testing if a high-quality ubiquinone (coenzyme Q10) supplement can improve symptoms, daily functioning, and life quality in those affected by Gulf War illness.

Participant Groups

Group I: CoQ10 Arm 1 Active Control 1 Intervention

PharmaNord Ubiquinone 100mg/1x day

Group II: CoQ10 Arm 2 Active Control 1 Intervention

PharmaNord Ubiquinone 100mg/3x day

Group III: Placebo Arm Placebo Group 1 Intervention

Placebo (made by PharmaNord, matches active treatment)

Bio-Quinone Active CoQ10 Gold 100mg is already approved in European Union, United States for the following indications:

Approved in European Union as Bio-Quinone Active CoQ10 Gold 100mg for:

• Heart health
• Cellular energy production

Approved in United States as Bio-Quinone Active CoQ10 Gold 100mg for:

• Dietary supplement for general health and wellness

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Oral ingestion of coenzyme Q10 (CoQ10) leads to increased plasma levels, with a plateau observed at a dose of 2400 mg for a specific chewable formulation, indicating a limit to absorption efficiency at higher doses.

Solubilized forms of CoQ10, including both ubiquinone and ubiquinol, demonstrate better bioavailability, resulting in higher plasma concentrations, which are essential for effective uptake in peripheral tissues and the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma coenzyme Q10 response to oral ingestion of coenzyme Q10 formulations. Bhagavan, HN., Chopra, RK.[2015]

In a study of 46 Gulf War veterans, Coenzyme Q10 (CoQ10) at a dose of 100 mg per day significantly improved general self-rated health and physical function compared to a placebo, particularly among male participants.

The results indicated that CoQ10 may help alleviate various symptoms associated with Gulf War illness, with a strong suggestion of causality based on the relationship between CoQ10 levels and health improvements, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. Golomb, BA., Allison, M., Koperski, S., et al.[2014]

Oral supplementation of coenzyme Q10 (CoQ10) significantly increased plasma CoQ10 levels in endurance athletes after 28 days, from 0.91 to 1.97 microgram/ml (p < .05).

Despite the increase in plasma CoQ10, the supplementation did not show a consistent significant impact on aerobic capacity or other performance metrics during graded cycling tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does exogenous coenzyme Q10 affect aerobic capacity in endurance athletes? Weston, SB., Zhou, S., Weatherby, RP., et al.[2019]

Ubiquinol-10 (QH(2)), the reduced form of Coenzyme Q(10), significantly reduces the release of pro-inflammatory cytokines and chemokines in human monocytic cells stimulated with lipopolysaccharide (LPS), indicating its potential as an anti-inflammatory agent.

Pre-incubation with QH(2) led to substantial decreases in TNF-alpha, MIP-1alpha, and RANTES levels, with reductions of 60.27%, 48.13%, and 74.36% respectively, demonstrating its efficacy in modulating inflammatory responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Effects of the Reduced Form of Coenzyme Q(10) on Secretion Levels of TNF-alpha and Chemokines in Response to LPS in the Human Monocytic Cell Line THP-1. Schmelzer, C., Lorenz, G., Rimbach, G., et al.[2022]

A study involving 24 healthy adults demonstrated that a novel CoQ10 oral preparation (COQUN®) effectively maintains high plasma concentrations of CoQ10 over time, with peak levels occurring 4 hours after a single dose.

The continuous administration of CoQ10 showed increasing plasma levels for up to 7 days, with no significant adverse events reported, suggesting its potential as a safe and effective antioxidant treatment for chronic diseases requiring elevated CoQ10 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability and Sustained Plasma Concentrations of CoQ10 in Healthy Volunteers by a Novel Oral Timed-Release Preparation. Martucci, A., Reurean-Pintilei, D., Manole, A.[2020]

Coenzyme Q10 (CoQ10) has a high safety profile, with an LD(50) greater than 20g/kg body weight in mice, indicating it is unlikely to cause acute toxicity at typical dosages.

A 30-day subacute toxicity study in rats showed no significant adverse effects or changes in health indicators, supporting the conclusion that CoQ10 is safe for oral consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute, subacute toxicity and genotoxic effect of Bio-Quinone Q10 in mice and rats. Fu, X., Ji, R., Dam, J.[2014]

Coenzyme Q10 (CoQ10) is considered safe for daily intake up to 1200 mg, with no significant increase in gastrointestinal side effects reported at this dosage compared to lower amounts, indicating a strong safety profile.

While higher doses of CoQ10 have been tested without adverse effects, there is insufficient data to confidently assess the safety of intakes above 1200 mg/day, suggesting that further research is needed for higher dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk assessment for coenzyme Q10 (Ubiquinone). Hathcock, JN., Shao, A.[2014]

Coenzyme Q10 (CoQ10) is a safe dietary supplement with low toxicity, showing no serious adverse effects in humans, and an acceptable daily intake of 12 mg/kg/day, which translates to about 720 mg for a 60 kg person.

Clinical studies indicate that CoQ10 does not accumulate in the body and does not affect the natural production of CoQ10, supporting its safety for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of coenzyme Q10 (CoQ10). Hidaka, T., Fujii, K., Funahashi, I., et al.[2022]

Ubiquinol, a form of coenzyme Q10, was found to be safe for healthy subjects, with no significant changes in laboratory tests, physical exams, or vital signs after doses up to 300 mg for 4 weeks.

The study demonstrated significant absorption of ubiquinol from the gastrointestinal tract, with plasma concentrations increasing non-linearly with dosage, indicating effective bioavailability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on safety and bioavailability of ubiquinol (Kaneka QH) after single and 4-week multiple oral administration to healthy volunteers. Hosoe, K., Kitano, M., Kishida, H., et al.[2015]

A study involving 16 healthy male subjects found that after taking 100 mg of deuterium-labelled coenzyme Q10 (d5-CoQ10), the peak plasma level reached 1.004 micrograms/ml approximately 6.5 hours later, indicating effective absorption.

The study revealed a unique plasma concentration curve with a second peak at 24 hours, suggesting that CoQ10 is absorbed by the liver and then redistributed into the bloodstream, which may influence its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic study of deuterium-labelled coenzyme Q10 in man. Tomono, Y., Hasegawa, J., Seki, T., et al.[2014]

Coenzyme Q10 (CoQ10) plays a crucial role in energy production and acts as an antioxidant, with deficiencies linked to aging, genetic factors, and certain medications like statins.

Supplementation with CoQ10 may improve symptoms related to mitochondrial deficiency and age-related conditions, as well as provide benefits for cardiovascular health, but more extensive and well-designed clinical trials are needed to confirm its efficacy in various diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 supplementation - In ageing and disease. Aaseth, J., Alexander, J., Alehagen, U.[2022]

A new high-performance liquid chromatography (HPLC) method was developed to accurately measure Coenzyme Q10 (CoQ10) levels in human plasma, achieving a detection limit of 8 ng on-column.

In a study of 31 healthy individuals aged 18 to 56, the average plasma CoQ10 level was found to be 0.47 mg/l, indicating a normal range of 0.26-1.03 mg/l, which can be useful for assessing CoQ10 status in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of coenzyme Q in human plasma. Kaplan, P., Sebestianová, N., Turiaková, J., et al.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Plasma coenzyme Q10 response to oral ingestion of coenzyme Q10 formulations. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Does exogenous coenzyme Q10 affect aerobic capacity in endurance athletes? [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

In Vitro Effects of the Reduced Form of Coenzyme Q(10) on Secretion Levels of TNF-alpha and Chemokines in Response to LPS in the Human Monocytic Cell Line THP-1. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Bioavailability and Sustained Plasma Concentrations of CoQ10 in Healthy Volunteers by a Novel Oral Timed-Release Preparation. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Acute, subacute toxicity and genotoxic effect of Bio-Quinone Q10 in mice and rats. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment for coenzyme Q10 (Ubiquinone). [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety assessment of coenzyme Q10 (CoQ10). [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Study on safety and bioavailability of ubiquinol (Kaneka QH) after single and 4-week multiple oral administration to healthy volunteers. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic study of deuterium-labelled coenzyme Q10 in man. [2014]

11. Ireland pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 supplementation - In ageing and disease. [2022]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

Determination of coenzyme Q in human plasma. [2016]