Can dietary supplementation with Krill-Oil improve Myalgia Encephalomyelitis/Chronic Fatigue Syndrome symptoms?

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 160

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue (MFI-20 questionnaire). A 20 -item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.[Baseline pre-supplementation,<br>Mid point (7-9 weeks) during supplementation ,<br>Post-supplementation (12 weeks after supplementation, primary endpoint)];Pain (McGill Pain Questionnaire), To evaluate a person experiencing significant pain.[Baseline pre-supplementation,<br>Mid point (7-9 weeks) during supplementation ,<br>Post-supplementation (12 weeks after supplementation, primary endpoint)];Sleep assessed as a composite of Actigraphy Watch: To monitor and measure sleep remotely through the data on the watch and the Pittsburg Sleep Quality Index Questionnaire: To monitor sleep habits. <br>[Baseline pre-supplementation,<br>Mid point (7-9 weeks) during supplementation ,<br>Post-supplementation (12 weeks after supplementation)]

Secondary Outcome Measures