Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001242718p
Ethics application status
Submitted, not yet approved
Date submitted
25/08/2022
Date registered
14/09/2022
Date last updated
14/09/2022
Date data sharing statement initially provided
14/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can dietary supplementation with Krill-Oil improve Myalgia Encephalomyelitis/Chronic Fatigue Syndrome symptoms?
Scientific title
Can dietary supplementation with Krill-Oil improve Myalgia Encephalomyelitis/Chronic Fatigue Syndrome symptoms in Adults?
Secondary ID [1] 307822 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome 327422 0
Myalgia Encephalomyelitis 327477 0
Condition category
Condition code
Other 324549 324549 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324289 0
Treatment: Other
Comparator / control treatment
Control group will consume 4g/day of SUPERBA placebo for 12 weeks. Each participant will consume 4 capsules once daily orally. Placebo contains mixture of olive oil, corn oil, palm oil and medium chain triglycerides in the ratio of 4:4:3:2.
Control group
Placebo

Outcomes
Primary outcome [1] 332373 0
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.
Timepoint [1] 332373 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation, primary endpoint)
Primary outcome [2] 332374 0
Pain (McGill Pain Questionnaire), To evaluate a person experiencing significant pain.
Timepoint [2] 332374 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation, primary endpoint)
Primary outcome [3] 332417 0
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.
Timepoint [3] 332417 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation)
Secondary outcome [1] 413240 0
Hand grip strength (hand held dynamometer) to measure their muscle strength and fatigue.
Timepoint [1] 413240 0
Baseline pre-supplementation,
Post-supplementation (12 weeks after supplementation).
Secondary outcome [2] 413433 0
Anthropometry: We will assess whole body composition estimates using Bioelectric impedance scale.
Timepoint [2] 413433 0
Baseline pre-supplementation,
Post-supplementation (12 weeks after supplementation).
Secondary outcome [3] 413436 0
Blood analyses for cytokine profiling using ELISA kit.
Timepoint [3] 413436 0
Baseline pre-supplementation,
Post-supplementation (12 weeks after supplementation).
Secondary outcome [4] 413438 0
Blood analyses for untargeted metabolomics using HPLC and proteomics.
Timepoint [4] 413438 0
Baseline pre-supplementation,
Post-supplementation (12 weeks after supplementation).
Secondary outcome [5] 413828 0
Physical activity assessed using an Actigraphy watch.
Timepoint [5] 413828 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation)
Secondary outcome [6] 413829 0
Brain fog assessed via You+ME symptom tracker.
Timepoint [6] 413829 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation)
Secondary outcome [7] 413830 0
Post Exertional malaise assessed via You+ME symptom tracker.
Timepoint [7] 413830 0
Baseline pre-supplementation,
Mid point (7-9 weeks) during supplementation ,
Post-supplementation (12 weeks after supplementation)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2022
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312093 0
Charities/Societies/Foundations
Name [1] 312093 0
The Mason Foundation
Country [1] 312093 0
Australia
Funding source category [2] 312096 0
University
Name [2] 312096 0
Deakin University
Country [2] 312096 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, VIC 3125, Australia
Country
Australia
Secondary sponsor category [1] 313617 0
None
Name [1] 313617 0
Address [1] 313617 0
Country [1] 313617 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311499 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 311499 0
221 Burwood Highway, Burwood, VIC 3125, Australia
Ethics committee country [1] 311499 0
Australia
Date submitted for ethics approval [1] 311499 0
25/07/2022
Approval date [1] 311499 0
Ethics approval number [1] 311499 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121314 0
Dr Lee Hamilton
Address 121314 0
Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 121314 0
Australia
Phone 121314 0
+61 392445207
Fax 121314 0
Email 121314 0
lee.hamilton@deakin.edu.au
Contact person for public queries
Name 121315 0
Dr Lee Hamilton
Address 121315 0
Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 121315 0
Australia
Phone 121315 0
+61 392445207
Fax 121315 0
Email 121315 0
lee.hamilton@deakin.edu.au
Contact person for scientific queries
Name 121316 0
Dr Lee Hamilton
Address 121316 0
Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 121316 0
Australia
Phone 121316 0
+61 392445207
Fax 121316 0
Email 121316 0
lee.hamilton@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected during trial, analysed, and stored in re-identifiable format so that we can provide individual feedback to participants on their responses to intervention. Results will be made available to participants if requested. The Principal Researchers will communicate these results to the participants or provide participants with a printed non-identifiable output of their results.
When will data be available (start and end dates)?
Start dates: December 2024, no end date.
Available to whom?
Participants
Available for what types of analyses?
Individual feedback to participants on their responses to intervention.
How or where can data be obtained?
Individual results will be available to the participants via email at the participant’s request. They will have the opportunity to contact the Principal Researcher by emailing (Lee.Hamilton@deakin.edu.au) to discuss their data in more detail if they would like.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.