Coenzyme Q10 for Gulf War Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of California, San Diego
Must not be taking: Coumadin/warfarin
Disqualifiers: Other clinical trials, Covid, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
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?
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.26789
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.35101112
Research Team
BA
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
See 3 more
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
See 1 more
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 (Coenzyme Q10)
Trial OverviewThe 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
3Treatment groups
Active Control
Placebo Group
Group I: CoQ10 Arm 1Active Control1 Intervention
PharmaNord Ubiquinone 100mg/1x day
Group II: CoQ10 Arm 2Active Control1 Intervention
PharmaNord Ubiquinone 100mg/3x day
Group III: Placebo ArmPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San DiegoLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Trials
1215
Patients Recruited
1,593,000+
United States Department of Defense
Collaborator
Trials
940
Patients Recruited
339,000+
References
Plasma coenzyme Q10 response to oral ingestion of coenzyme Q10 formulations. [2015]Plasma coenzyme Q10 (CoQ10) response to oral ingestion of various CoQ10 formulations was examined. Both total plasma CoQ10 and net increase over baseline CoQ10 concentrations show a gradual increase with increasing doses of CoQ10. Plasma CoQ10 concentrations plateau at a dose of 2400 mg using one specific chewable tablet formulation. The efficiency of absorption decreases as the dose increases. About 95% of circulating CoQ10 occurs as ubiquinol, with no appreciable change in the ratio following CoQ10 ingestion. Higher plasma CoQ10 concentrations are necessary to facilitate uptake by peripheral tissues and also the brain. Solubilized formulations of CoQ10 (both ubiquinone and ubiquinol) have superior bioavailability as evidenced by their enhanced plasma CoQ10 responses.
Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. [2014]We sought to assess whether coenzyme Q10 (CoQ10) benefits the chronic multisymptom problems that affect one-quarter to one-third of 1990-1 Gulf War veterans, using a randomized, double-blind, placebo-controlled study. Participants were 46 veterans meeting Kansas and Centers for Disease Control criteria for Gulf War illness. Intervention was PharmaNord (Denmark) CoQ10 100 mg per day (Q100), 300 mg per day (Q300), or an identical-appearing placebo for 3.5 ± 0.5 months. General self-rated health (GSRH), the primary outcome, differed across randomization arms at baseline, and sex significantly predicted GSRH change, compelling adjustment for baseline GSRH and prompting sex-stratified analysis. GSRH showed no significant benefit in the combined-sex sample. Among males (85% of participants), Q100 significantly benefited GSRH versus placebo and versus Q300, providing emphasis on Q100. Physical function (summary performance score, SPS) improved on Q100 versus placebo. A rise in CoQ10 approached significance as a predictor of improvement in GSRH and significantly predicted SPS improvement. Among 20 symptoms each present in half or more of the enrolled veterans, direction-of-difference on Q100 versus placebo was favorable for all except sleep problems; sign test 19:1, p=0.00004) with several symptoms individually significant. Significance for these symptoms despite the small sample underscores large effect sizes, and an apparent relation of key outcomes to CoQ10 change increases prospects for causality. In conclusion, Q100 conferred benefit to physical function and symptoms in veterans with Gulf War illness. Examination in a larger sample is warranted, and findings from this study can inform the conduct of a larger trial.
Does exogenous coenzyme Q10 affect aerobic capacity in endurance athletes? [2019]The effect of orally supplemented coenzyme Q10 (CoQ10) on plasma CoQ10 concentration and aerobic capacity in endurance athletes was evaluated. Eighteen volunteer male road cyclists and triathletes, 8 in a CoQ10 supplementation group (QG) and 10 in a placebo group (PG), successfully completed the experimental protocol. Subjects were evaluated during and following graded cycling exercise tests, which were performed before and after 28 days of supplementation with 1 mg.kg-1.day-1 of CoQ10 or placebo. The presupplementation plasma CoQ10 concentration was significantly increased from 0.91 +/- 0.13 microgram.ml-1 to 1.97 +/- 0.27 microgram.ml-1 in QG following supplementation (p
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]Ubiquinol-10 (QH(2)), the reduced form of Coenzyme Q(10) (CoQ(10)) serves as a potent antioxidant of lipid membranes. Because many antioxidants reveal potent anti-inflammatory effects, the influence of QH(2) on lipopolysaccharide (LPS)-induced pro-inflammatory cytokines and chemokines were determined in the human monocytic cell line THP-1. Stimulation of cells with LPS resulted in a distinct release of Tumour necrosis factor-alpha (TNF-alpha), Macrophage inflammatory protein-1 alpha (MIP-1alpha), Regulated upon activation, normal T cell expressed and secreted (RANTES) and Monocyte chemotattractant protein-1 (MCP-1). The LPS-induced responses were significantly decreased by pre-incubation of cells with QH(2) to 60.27 +/- 9.3% (p = 0.0009), 48.13 +/- 6.93% (p = 0.0007) and 74.36 +/- 7.25% (p = 0.008) for TNF-alpha, MIP-1alpha and RANTES, respectively. In conclusion, our results indicate anti-inflammatory effects of the reduced form of CoQ(10) on various proinflammatory cytokines and chemokines in vitro.
Bioavailability and Sustained Plasma Concentrations of CoQ10 in Healthy Volunteers by a Novel Oral Timed-Release Preparation. [2020]Coenzyme Q10 (CoQ10) is a natural compound with potent antioxidant properties. Its provision through diet does not always allow adequate levels in the human body, and supplementation is often necessary. This bioavailability study intended to explore the plasma concentration levels of a novel CoQ10 oral preparation (COQUN®, Coenzyme Q10 Miniactives Retard 100 mg capsules) mimicking assumption on a regular basis. Twenty-four healthy adults tested a single dose of CoQ10 100 mg in one day to assess bioavailability. After a one week wash-out period, they were randomly assigned (1:1) to continuous administration for four weeks: Group A (n = 12) 100 mg once a day (OD); and Group B (n = 12) 100 mg twice a day (BID). During the single dose phase, Cmax was observed at 4 h, and the mean values of AUCt and Tmax were 8754 μg/mL·h and 4.29 h, respectively. The multiple dose phase showed increasing plasma levels up to 7 days after the start of administration, and sustained high concentrations during the all administration period. No relevant adverse events were reported. These results show that Miniactives® technology can release CoQ10 to allow high constant blood concentrations without a sharp decrease. This may be the first step of evidence for a potential new antioxidative treatment in human chronic diseases deserving high CoQ10 levels.
Acute, subacute toxicity and genotoxic effect of Bio-Quinone Q10 in mice and rats. [2014]In the present study, the acute, subacute and genetic toxicity of Coenzyme Q10 (CoQ10) in the form of Bio-Quinone (Pharma Nord, Denmark) was assessed. LD(50) of CoQ10 by oral treatment was greater than 20g/kg body weight in both female and male mice. Genotoxicity was assessed in mice by Ames test in Salmonella typhimurium strains TA97, TA98, TA100 and TA102, by bone marrow micronucleus test and sperm abnormality. Thirty-day subacute toxicity was conducted with oral daily dose at 0, 0.56, 1.13 and 2.25g/kg body weight in rats. No significant changes in body weight, food intake, behavior, mortality, hematology, blood biochemistry, vital organ weight, sperm abnormality, mutagenicity and micronucleus formation were observed and no clinical signs or adverse effects were detected by administration of CoQ10. These results support the safety of CoQ10 for oral consumption.
Risk assessment for coenzyme Q10 (Ubiquinone). [2014]Coenzyme Q10 (CoQ10) widely occurs in organisms and tissues, and is produced and used as both a drug and dietary supplement. Increasing evidence of health benefits of orally administered CoQ10 are leading to daily consumption in larger amounts, and this increase justifies research and risk assessment to evaluate the safety. A large number of clinical trials have been conducted using a range of CoQ10 doses. Reports of nausea and other adverse gastrointestinal effects of CoQ10 cannot be causally related to the active ingredient because there is no dose-response relationship: the adverse effects are no more common at daily intakes of 1200 mg than at a 60 mg. Systematic evaluation of the research designs and data do not provide a basis for risk assessment and the usual safe upper level of intake (UL) derived from it unless the newer methods described as the observed safe level (OSL) or highest observed intake (HOI) are utilized. The OSL risk assessment method indicates that the evidence of safety is strong at intakes up to 1200 mg/day, and this level is identified as the OSL. Much higher levels have been tested without adverse effects and may be safe, but the data for intakes above 1200 mg/day are not sufficient for a confident conclusion of safety.
Safety assessment of coenzyme Q10 (CoQ10). [2022]Coenzyme Q10 (CoQ10) is a naturally occurring component present in living cells. Its physiological function is to act as an essential cofactor for ATP production, and to perform important antioxidant activities in the body. In most countries, CoQ10 has been widely used as a dietary supplement for more than 20 years. Recently, the use of CoQ10 as a dietary supplement has grown with a corresponding increase in daily dosage. The present review describes the safety profile of CoQ10 on the basis of animal and human data. The published reports concerning safety studies indicate that CoQ10 has low toxicity and does not induce serious adverse effects in humans. The acceptable daily intake (ADI) is 12mg/kg/day, calculated from the no-observed-adverse-effect level (NOAEL) of 1200 mg/kg/day derived from a 52-week chronic toxicity study in rats, i.e., 720 mg/day for a person weighing 60 kg. Risk assessment for CoQ10 based on various clinical trial data indicates that the observed safety level (OSL) for CoQ10 is 1200 mg/day/person. Evidence from pharmacokinetic studies suggest that exogenous CoQ10 does not influence the biosynthesis of endogenous CoQ9/CoQ10 nor does it accumulate into plasma or tissues after cessation of supplementation. Overall, these data from preclinical and clinical studies indicate that CoQ10 is highly safe for use as a dietary supplement. Additionally, analysis of CoQ10 bioavailability or its pharmacokinetics provides the pertinent safety evaluation for CoQ10.
Study on safety and bioavailability of ubiquinol (Kaneka QH) after single and 4-week multiple oral administration to healthy volunteers. [2015]The safety and bioavailability of ubiquinol (the reduced form of coenzyme Q(10)), a naturally occurring lipid-soluble nutrient, were evaluated for the first time in single-blind, placebo-controlled studies with healthy subjects after administration of a single oral dose of 150 or 300 mg and after oral administration of 90, 150, or 300 mg for 4 weeks. No clinically relevant changes in results of standard laboratory tests, physical examination, vital signs, or ECG induced by ubiquinol were observed in any dosage groups. The C(max) and AUC(0-48 h) derived from the mean plasma ubiquinol concentration-time curves increased non-linearly with dose from 1.88 to 3.19 micro g/ml and from 74.61 to 91.76 micro g h/ml, respectively, after single administration. Trough concentrations had nearly plateaued at levels of 2.61 micro g/ml for 90 mg, 3.66 micro g/ml for 150 mg, and 6.53 micro g/ml for 300 mg at day 14, and increased non-linearly with dose in the 4-week study. In conclusion, following single or multiple-doses of ubiquinol in healthy volunteers, significant absorption of ubiquinol from the gastrointestinal tract was observed, and no safety concerns were noted on standard laboratory tests for safety or on assessment of adverse events for doses of up to 300 mg for up to 2 weeks after treatment completion.
Pharmacokinetic study of deuterium-labelled coenzyme Q10 in man. [2014]The pharmacokinetics of coenzyme Q10 (CoQ10) in man was studied by utilizing deuterium-labelled coenzyme Q10 (d5-CoQ10). The absence of an isotope effect in the disposition of d5-CoQ10 in man was confirmed from the plasma concentration time curves after simultaneous oral dosing of d5-CoQ10 and unlabelled CoQ10. After oral administration of 100 mg of d5-CoQ10 to 16 healthy male subjects, the mean plasma CoQ10 level attained a peak of 1.004 +/- 0.370 micrograms/ml at 6.5 +/- 1.5 h after administration, and the terminal elimination half-life was 33.19 +/- 5.32 h. In most of the subjects, plasma d5-CoQ10 showed a second peak at 24 h after dosing. This unusual plasma level curve was well described by a newly proposed compartment model based upon the assumption that absorbed CoQ10 is taken up by the liver and then transferred mainly to VLDL and redistributed from the liver to the systemic blood.
Coenzyme Q10 supplementation - In ageing and disease. [2022]Coenzyme Q10 (CoQ10) is an essential component of the mitochondrial electron transport chain. It is also an antioxidant in cellular membranes and lipoproteins. All cells produce CoQ10 by a specialized cytoplasmatic-mitochondrial pathway. CoQ10 deficiency can result from genetic failure or ageing. Some drugs including statins, widely used by inter alia elderly, may inhibit endogenous CoQ10 synthesis. There are also chronic diseases with lower levels of CoQ10 in tissues and organs. High doses of CoQ10 may increase both circulating and intracellular levels, but there are conflicting results regarding bioavailability. Here, we review the current knowledge of CoQ10 biosynthesis and primary and acquired CoQ10 deficiency, and results from clinical trials based on CoQ10 supplementation. There are indications that supplementation positively affects mitochondrial deficiency syndrome and some of the symptoms of ageing. Cardiovascular disease and inflammation appear to be alleviated by the antioxidant effect of CoQ10. There is a need for further studies and well-designed clinical trials, with CoQ10 in a formulation of proven bioavailability, involving a greater number of participants undergoing longer treatments in order to assess the benefits of CoQ10 treatment in neurodegenerative disorders, as well as in metabolic syndrome and its complications.
Determination of coenzyme Q in human plasma. [2016]Coenzyme Q10 (CoQ10) levels in human plasma were determined by high-performance liquid chromatography (HPLC) with UV detection. CoQ10 was dissociated from lipoproteins by methanol and subsequently cleaned-up on silica gel and octadecyl silica solid-phase extraction cartridges. HPLC separation was performed on a C18 reversed-phase column. The methanol-hexane mobile phase provided a greater possibility of separation procedure adjustment allowing the shortest possible elution time without loss of resolution than a two-alcohol mobile phase. Quantitation was based on the peak heights using a standard addition method. The lower limit of detection was 8 ng on-column, corresponding to 90 micrograms ubiquinone per litre of plasma in an actual sample. Thirty-one randomly selected plasma samples from apparently healthy, 18 to 56-year-old individuals (males and females) were analyzed for total CoQ10. The average level in these subjects was 0.47 +/- 0.18 mg/l with the range of 0.26-1.03 mg/l. The method was also applied to the determination of ubiquinone plasma level changes in one healthy volunteer over a period of one month and after oral intake of CoQ10.