ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Fatigue Syndrome

Myalgia Encephalomyelitis

Condition category

Condition code

Other

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]

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]

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]

Baseline pre-supplementation, Mid point (7-9 weeks) during supplementation , Post-supplementation (12 weeks after supplementation, primary endpoint)

Primary outcome [2]

Pain (McGill Pain Questionnaire), To evaluate a person experiencing significant pain.

Timepoint [2]

Baseline pre-supplementation, Mid point (7-9 weeks) during supplementation , Post-supplementation (12 weeks after supplementation, primary endpoint)

Primary outcome [3]

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]

Baseline pre-supplementation, Mid point (7-9 weeks) during supplementation , Post-supplementation (12 weeks after supplementation)

Secondary outcome [1]

Hand grip strength (hand held dynamometer) to measure their muscle strength and fatigue.

Timepoint [1]

Baseline pre-supplementation, Post-supplementation (12 weeks after supplementation).

Secondary outcome [2]

Anthropometry: We will assess whole body composition estimates using Bioelectric impedance scale.

Timepoint [2]

Baseline pre-supplementation, Post-supplementation (12 weeks after supplementation).

Secondary outcome [3]

Blood analyses for cytokine profiling using ELISA kit.

Timepoint [3]

Baseline pre-supplementation, Post-supplementation (12 weeks after supplementation).

Secondary outcome [4]

Blood analyses for untargeted metabolomics using HPLC and proteomics.

Timepoint [4]

Baseline pre-supplementation, Post-supplementation (12 weeks after supplementation).

Secondary outcome [5]

Physical activity assessed using an Actigraphy watch.

Timepoint [5]

Baseline pre-supplementation, Mid point (7-9 weeks) during supplementation , Post-supplementation (12 weeks after supplementation)

Secondary outcome [6]

Brain fog assessed via You+ME symptom tracker.

Timepoint [6]

Baseline pre-supplementation, Mid point (7-9 weeks) during supplementation , Post-supplementation (12 weeks after supplementation)

Secondary outcome [7]

Post Exertional malaise assessed via You+ME symptom tracker.

Timepoint [7]

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?

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]

Charities/Societies/Foundations

Name [1]

The Mason Foundation

Address [1]

Level 1, 575 Bourke Street, Melbourne, VIC 3000, Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

Deakin University

Address [2]

221 Burwood Highway, Burwood, VIC 3125, Australia

Country [2]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Highway, Burwood, VIC 3125, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

221 Burwood Highway, Burwood, VIC 3125, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/07/2022

Approval date [1]

Ethics approval number [1]

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

Dr Lee Hamilton

Address

Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216

Country

Australia

Phone

+61 392445207

Fax

[email protected]

Contact person for public queries

Name

Lee Hamilton

Address

Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216

Country

Australia

Phone

+61 392445207

Fax

[email protected]

Contact person for scientific queries

Name

Lee Hamilton

Address

Deakin University, Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216

Country

Australia

Phone

+61 392445207

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Participants

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?

• Individual feedback to participants on their responses to intervention.

When can requests for individual participant data be made (start and end dates)?

From:
Start dates: December 2024, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• 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 ([email protected]) to discuss their data in more detail if they would like.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically