None listed
Conditions
Brief summary
Myalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS) is a severe, chronic disease with an estimated prevalence of 0.76% in the Australian population. Post-exertional malaise (PEM) is the key symptom of ME/CFS which can last for several weeks or months, where patients have an exacerbation of symptoms (chronic fatigue, headaches, sleep disturbance, brain fog etc) following exertion, that cannot be relieved by sleep or rest. Simple everyday activities (such as walking and showers) can trigger PEM. Patients may face years of persistent symptoms including fatigue, PEM, sleep disturbance, impaired cognition, mood disturbance and muscle and/or joint pain. Despite the debilitating nature of its symptoms and high personal and socio-economic burden, there is no clear understanding of the underlying pathophysiology of the disease and no effective treatments . ME/CFS is a complex multisystem disease with potential involvement of the immune system, nervous system, and the musculoskeletal system in addition to nociception, mitochondria metabolism, and oxidative defence mechanisms. To be efficacious, potential treatments will need to target multiple systems and multiple processes to meaningfully impact quality of life. We believe that krill oil is a potential treatment option. Krill oil is a sustainable source of the long chain omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is also high in the antioxidant astaxanthin and the essential nutrient choline. EPA and DHA play critical roles in brain and metabolic function, in addition to being potent anti-inflammatory agents with analgesic properties. It is also known to improve cognitive and sleep quality. Choline plays an important role in the nervous system and energy metabolism while astaxanthin is a potent antioxidant proven to improve oxidative stress in humans. These compounds have systemic biological actions, and they have the potential to alleviate some of the systemic disruptions associated with ME/CFS such as brain fog, chronic pain and sleep disturbance resulting in reduced fatigue. Therefore, we propose that krill oil may be a viable treatment option for ME/CFS.
Interventions
Intervention group will consume SUPERBA Krill Oil oral capsule 4g once daily for 12 weeks. Each capsule contains 1g of Krill oil, therefore each participant will consume 4 capsules orally.
Adherence to intervention will be monitored by counting the capsules at post-supplementation testing.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 and above, either male or female. 2. Clinically diagnosed with ME/CFS by an independent physician and fulfil the criteria for ME/CFS using the Multidimensional fatigue inventory (MFI-20). 3. Participants currently under any form of therapy for ME/CFS will need to have been on that therapy for at least 8 weeks prior to enrolment. 3. Ability to consent to the study and comply with study procedures as ascertained by research interviewer. 4. English speaker
Exclusion criteria
1. Aged <18 2Medical condition that explains chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, medication side effects, and diagnosed iron deficiency) 3. Previous diagnosis not resolved (chronic hepatitis, malignancy) 5. Known or suspected systemic medical disorder such as rheumatoid arthritis or any serious medical condition (e.g. cognitive disorder, intellectual disability, Alzheimer’s disease). 6. Current diagnosis of a psychotic disorder, bipolar disorder, substance abuse/dependence, eating disorder, or significant personality disorder 7. Participation in another trial within 30 days prior to study inclusion 8. Inability to be randomised to a treatment arm 9. Inability to provide written informed consent 10.Medications/supplements that might influence nutrient absorption or outcome measures in the last 90 days 11. Patients on blood thinning medication or at risk of bleeding 12. Pregnant or breast-feeding 13. Smoking, substance/alcohol abuse 14. Allergy to shellfish or never consumed shellfish (to avoid those with an unknown allergy).
Outcome results
None listed