- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128292
Effect of CoQ10 Plus Selenium Supplementation on Clinical Outcomes and Biochemical Markers in ME/CFS (CoSeME Study) (CoSeME)
November 16, 2021 updated by: Hospital Universitari Vall d'Hebron Research Institute
Role of the NLRP3 Inflammasome Activation, Mitochondrial Biogenesis, and Immunoinflammatory Response After Oral Coenzyme Q10 Plus Selenium Supplementation in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
In recent years, it has been suggested that nutritional deficiencies may be of causal relevance in individuals with ME/CFS.
These include deficiencies of vitamins and trace elements.
It is likely that the observed nutritional deficiencies contribute to the core symptoms of the disease.
Coenzyme Q10 (CoQ10) has been studied as an alternative and complementary therapy in ME/CFS for fatigue, pain, tiredness, neurocognitive impairment, and sleep problems.
This demonstrates how alterations in energy metabolism, mitochondrial dysfunction, oxidative stress, imbalance of the immune-inflammatory response, and activation of the NLRP3 inflammasome are likely consequences of low levels of CoQ10 and selenium, which are related to the main symptoms in ME/CFS.
Hypothesis: CoQ10 and selenium levels are decreased in ME/CFS patients.
A natural therapeutic alternative in the treatment of common symptoms in ME/CFS could be the oral CoQ10 (Ubiquinone) plus selenium supplementation to module redox status and inflammation response in ME/CFS.
Aims: To evaluate the efficacy of oral Ubiquinone + selenium supplementation on clinical outcome and circulating biomarkers in ME/CFS.
We enrolled 42 ME/CFS patients diagnosed according to the 1994 CDC/Fukuda criteria who have received oral treatment of 400 mg Ubiquinone + 200 microgram selenium daily for 8 weeks.
Demographic, clinical characteristics and laboratory variables, and validated outcome measures to perceived fatigue, sleep disturbances, and quality of life will be also evaluated.
In addition, plasma biomarkers related to oxidative stress status (total antioxidant capacity and lipoperoxide levels), inflammatory response (pro-and anti-inflammatory cytokines), and cardiovascular dysfunction (FGF-21 and NT-proBNP) will be assayed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cataluña
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Barcelona, Cataluña, Spain, 08035
- Vall D'Hebron University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients were potentially eligible if they were female, aged 18 years or older, and had a confirmed diagnosis of ME/CFS by a specialist according to the 1994 CDC/Fukuda criteria
Exclusion Criteria:
- Exclusion criteria were those with any significant active fatiguing medical disorder (thyroid-related disorders, sleep apnea, narcolepsy, medication side-effects, heart diseases, iron deficiency anemia), previous diagnosis not unequivocally resolved (chronic hepatitis, malignancy), autoimmune disorders, history of past/current neuropsychiatric disorders (major depressive disorder, psychotic or melancholic features, bipolar disorder, schizophrenia, delusional disorder, dementias, anorexia nervosa, and bulimia nervosa), and participation in another clinical trial of the same or different nature within 30 days prior to study inclusion; inability (in the opinion of the investigator) to follow the instructions or to complete the treatment satisfactorily; failure to provide signed informed consent; use of certain drugs and supplements that might influence outcome measures in the last 90 days or whose withdrawal might be a relevant problem, anticoagulant treatment, pregnancy or breast-feeding, smoking habits, alcohol intake or substance abuse, strong hormone-related medications, and obesity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CoQ10 plus selenium
Nutraceutical intervention: 400 mg/day CoQ10 soft gel capsula (Bio-Quinone active 100 mg b.i.d) plus 200 microgram organic selenium yeast tablet (SelenoPrecise 100 microgram b.i.d.) over 8 weeks |
400 mg/day CoQ10 soft gel capsula (Bio-Quinone active 100 mg b.i.d) plus 200 microgram organic selenium yeast tablet (SelenoPrecise 100 microgram b.i.d.) over 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue perception assessed through FIS-40 questionnaire
Time Frame: 8 weeks
|
FIS-40 self-reported questionnaire: Change of fatigue perception from baseline will be assessed.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep disturbances evaluated through PSQI
Time Frame: 8 weeks
|
Change of sleep problems from baseline will be assessed.
|
8 weeks
|
Health-related quality of life assessed by SF-36
Time Frame: 8 weeks
|
Change of quality of life (SF-36) from baseline will be assessed.
|
8 weeks
|
Measurement of biomarkers of redox status.
Time Frame: 8 weeks
|
Change of the circulating biomarker levels of oxidative stress (malondialdehydes and total antioxidant capacity) from baseline will be measured.
|
8 weeks
|
Measurement of biomarkers of inflammatory immune response.
Time Frame: 8 weeks
|
Change of the circulating biomarker levels of inflammatory cytokines (IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, and C-reactive protein) from baseline will be measured.
|
8 weeks
|
Measurement of biomarkers of cardiovascular risk.
Time Frame: 8 weeks
|
Change of the circulating biomarker levels of cardiovascular function (FGF-21 and NT-proBNP) from baseline will be measured.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: José Alegre, MD, PhD, Vall D'Hebron University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bjorklund G, Dadar M, Pen JJ, Chirumbolo S, Aaseth J. Chronic fatigue syndrome (CFS): Suggestions for a nutritional treatment in the therapeutic approach. Biomed Pharmacother. 2019 Jan;109:1000-1007. doi: 10.1016/j.biopha.2018.10.076. Epub 2018 Nov 5.
- Morris G, Puri BK, Walker AJ, Maes M, Carvalho AF, Walder K, Mazza C, Berk M. Myalgic encephalomyelitis/chronic fatigue syndrome: From pathophysiological insights to novel therapeutic opportunities. Pharmacol Res. 2019 Oct;148:104450. doi: 10.1016/j.phrs.2019.104450. Epub 2019 Sep 8.
- Testai L, Martelli A, Flori L, Cicero AFG, Colletti A. Coenzyme Q10: Clinical Applications beyond Cardiovascular Diseases. Nutrients. 2021 May 17;13(5):1697. doi: 10.3390/nu13051697.
- Fukuda S, Nojima J, Kajimoto O, Yamaguti K, Nakatomi Y, Kuratsune H, Watanabe Y. Ubiquinol-10 supplementation improves autonomic nervous function and cognitive function in chronic fatigue syndrome. Biofactors. 2016 Jul 8;42(4):431-40. doi: 10.1002/biof.1293. Epub 2016 Apr 29.
- Maes M, Mihaylova I, Kubera M, Uytterhoeven M, Vrydags N, Bosmans E. Coenzyme Q10 deficiency in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is related to fatigue, autonomic and neurocognitive symptoms and is another risk factor explaining the early mortality in ME/CFS due to cardiovascular disorder. Neuro Endocrinol Lett. 2009;30(4):470-6.
- Nacul L, Authier FJ, Scheibenbogen C, Lorusso L, Helland IB, Martin JA, Sirbu CA, Mengshoel AM, Polo O, Behrends U, Nielsen H, Grabowski P, Sekulic S, Sepulveda N, Estevez-Lopez F, Zalewski P, Pheby DFH, Castro-Marrero J, Sakkas GK, Capelli E, Brundsdlund I, Cullinan J, Krumina A, Bergquist J, Murovska M, Vermuelen RCW, Lacerda EM. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): Expert Consensus on the Diagnosis, Service Provision, and Care of People with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510. doi: 10.3390/medicina57050510.
- Castro-Marrero J, Cordero MD, Segundo MJ, Saez-Francas N, Calvo N, Roman-Malo L, Aliste L, Fernandez de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid Redox Signal. 2015 Mar 10;22(8):679-85. doi: 10.1089/ars.2014.6181. Epub 2014 Dec 18.
- Campagnolo N, Johnston S, Collatz A, Staines D, Marshall-Gradisnik S. Dietary and nutrition interventions for the therapeutic treatment of chronic fatigue syndrome/myalgic encephalomyelitis: a systematic review. J Hum Nutr Diet. 2017 Jun;30(3):247-259. doi: 10.1111/jhn.12435. Epub 2017 Jan 22.
- Castro-Marrero J, Saez-Francas N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernandez de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. Clin Nutr. 2016 Aug;35(4):826-34. doi: 10.1016/j.clnu.2015.07.010. Epub 2015 Jul 17.
- Castro-Marrero J, Segundo MJ, Lacasa M, Martinez-Martinez A, Sentanes RS, Alegre-Martin J. Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2021 Jul 30;13(8):2658. doi: 10.3390/nu13082658.
- Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.
- Maksoud R, Balinas C, Holden S, Cabanas H, Staines D, Marshall-Gradisnik S. A systematic review of nutraceutical interventions for mitochondrial dysfunctions in myalgic encephalomyelitis/chronic fatigue syndrome. J Transl Med. 2021 Feb 17;19(1):81. doi: 10.1186/s12967-021-02742-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
September 1, 2018
Study Completion (ACTUAL)
November 30, 2018
Study Registration Dates
First Submitted
November 5, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (ACTUAL)
November 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 19, 2021
Last Update Submitted That Met QC Criteria
November 16, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Virus Diseases
- Infections
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Musculoskeletal Pain
- Central Nervous System Infections
- Myalgia
- Fatigue Syndrome, Chronic
- Encephalomyelitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Trace Elements
- Micronutrients
- Antioxidants
- Selenium
Other Study ID Numbers
- PR(AG)233(2016)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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