Myalgic Encephalomyelitis
Conditions
Keywords
fatigue, Coenzyme Q10, selenium, sleep disturbances, biomarkers, myalgic encephalomyelitis, chronic fatigue syndrome
Brief 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.
Interventions
DIETARY_SUPPLEMENTCoQ10 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
Sponsors
Pharma Nord
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue perception assessed through FIS-40 questionnaire | 8 weeks | FIS-40 self-reported questionnaire: Change of fatigue perception from baseline will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbances evaluated through PSQI | 8 weeks | Change of sleep problems from baseline will be assessed. |
| Health-related quality of life assessed by SF-36 | 8 weeks | Change of quality of life (SF-36) from baseline will be assessed. |
| Measurement of biomarkers of redox status. | 8 weeks | Change of the circulating biomarker levels of oxidative stress (malondialdehydes and total antioxidant capacity) from baseline will be measured. |
| Measurement of biomarkers of inflammatory immune response. | 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. |
| Measurement of biomarkers of cardiovascular risk. | 8 weeks | Change of the circulating biomarker levels of cardiovascular function (FGF-21 and NT-proBNP) from baseline will be measured. |
Countries
Spain
Outcome results
None listed