Effect of CoQ10 Plus Selenium Supplementation on Clinical Outcomes and Biochemical Markers in ME/CFS (CoSeME Study)

Myalgic Encephalomyelitis Clinical Trial

— CoSeME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128292
• Other study ID #: PR(AG)233(2016)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 30, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalomyelitis
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis

Intervention

Dietary Supplement:
• CoQ10 plus Selenium
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

Locations

Country	Name	City	State
Spain	Vall d'Hebron University Hospital	Barcelona	Cataluña

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Pharma Nord

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Bjørklund 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. Review. — View Citation

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. do — View Citation

Castro-Marrero J, Cordero MD, Sáez-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 N — View Citation

Castro-Marrero J, Cordero MD, Segundo MJ, Sáez-Francàs N, Calvo N, Román-Malo L, Aliste L, Fernández de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid — View Citation

Castro-Marrero J, Sáez-Francàs N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernández de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndro — View Citation

Castro-Marrero J, Segundo MJ, Lacasa M, Martinez-Martinez A, Sentañes 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/Chro — View Citation

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. — View Citation

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. — View Citation

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: 1 — View Citation

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. Review. — View Citation

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, Estévez-López 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). pii: 510. doi: 10.3390/medicina57050510. — View Citation

Testai L, Martelli A, Flori L, Cicero AFG, Colletti A. Coenzyme Q(10): Clinical Applications beyond Cardiovascular Diseases. Nutrients. 2021 May 17;13(5). pii: 1697. doi: 10.3390/nu13051697. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue perception assessed through FIS-40 questionnaire	FIS-40 self-reported questionnaire: Change of fatigue perception from baseline will be assessed.	8 weeks
Secondary	Sleep disturbances evaluated through PSQI	Change of sleep problems from baseline will be assessed.	8 weeks
Secondary	Health-related quality of life assessed by SF-36	Change of quality of life (SF-36) from baseline will be assessed.	8 weeks
Secondary	Measurement of biomarkers of redox status.	Change of the circulating biomarker levels of oxidative stress (malondialdehydes and total antioxidant capacity) from baseline will be measured.	8 weeks
Secondary	Measurement of biomarkers of inflammatory immune response.	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
Secondary	Measurement of biomarkers of cardiovascular risk.	Change of the circulating biomarker levels of cardiovascular function (FGF-21 and NT-proBNP) from baseline will be measured.	8 weeks