Clinical Trials

The effect of functional foods intervention on common symptoms such as fatigue and depression in patients with multiple sclerosis

Type of Study/Intervention

Nutraceutical - Allied Health

Recruitment Status

Pending

Form of MS

Relapsing remitting MS

Brief summary

Multiple sclerosis (MS) is rare but increasing in incidence. Our Australian work shows that five years of a first demyelinating event, 41% of people will have clinical fatigue with depression frequently comorbid. Single nutrient therapy with antioxidants directed to mitochondrial support have shown some benefit for fatigue and depression, oxidant damage prevention and improved clinical course in multiple sclerosis. This double-blind randomised controlled trial will run a 20-week therapy of combined mitochondrial support agents against placebo. The therapy will include coenzyme Q10, alpha-lipoic acid, N acetyl cysteine, biotin and other agents. Trial participants will be people with relapsing remitting multiple sclerosis with fatigue. The trial will assess the extent that these therapies reduce fatigue, depression, and metabolomic abnormalities in MS.

Inclusion criteria

• Aged 18-65 years;
• Diagnosed with RRMS by a neurologist;
• EDSS of less than 6 within last 12 months (measurement recorded in the absence of an acute relapse or illness);
• English speaking or non-English speaking patients that can ensure external interpreter assistance (e.g. from a relative, spouse or friend) for the onsite clinical visits and for the phone follow-up timepoints.
• On stable MS therapy for more than/ equal to 8 weeks prior to enrolment;
• Available to attend clinic visits within 1 week of each time point (baseline, week 16, and week 20);
• Clinical fatigue (as evidenced by a FSS score more than 4 on two occasions when completing the test serially online over a fortnight);
• Basic confidence and literacy with using a computer (e.g. able to use web browser, receive SMS messages).

Exclusion criteria

• Known or suspected systemic medical disorder such as rheumatoid arthritis and kidney disease OR any medical condition (e.g. cognitive disorders, intellectual disability, Alzheimer’s disease) that investigators determine may affect participant adherence to the trial intervention
• Previous cardiac event including angina, Coronary Artery Bypass Grafting (CABG), non- and ST elevated myocardial infarction (biotin can disrupt measurement of cardiac enzymes)
• Currently prescribed thyroid-related medication (e.g. thyroxine) or diagnosed thyroid-related disorder
• Pre-existing psychotropic therapy regimen needs to have been stable for 4 weeks prior to study entry

• Pregnant or at risk of pregnancy (if female);
• Current lactation;
• Commenced or are scheduled to commence iron supplementation
• Acute suicidality (score more than 1 on item 12 of a self-reported Quick Inventory of Depressive Symptomology Tool);
• A current diagnosis of substance abuse/dependence;
• Currently taking any illicit substances including any cannabis product (e.g. cannabis oil)
• Recent gastrointestinal ulcers or renal stones;
• Diagnosis of epilepsy;
• Current use of any of the study preparations OR any multivitamin (eligible following a 3-week washout period);
• Using more than 200 mcg of selenium/day (antioxidant properties that are mechanistically similar to the study treatment).
• Prescribed warfarin or phenytoin;
• Allergy/intolerance to any study components;
• No internet access;
• Unable or unlikely to attend the required study visits at the required timepoints or unable to complete the study protocol (e.g. upcoming travel, surgery)

Anticipated start date

01/11/2019

Recruitment contacts

Contact your neurologist at participating site (the Royal Melbourne Hospital; the Austin Hospital; the University of Tasmania, as represented by the Menzies Institute for Medical Research; The Alfred Health, Victoria; John Hunter Hospital, Newcastle; and Griffith University, Queensland)

If your neurologist is not at the above site and you are interested in participating please email [email protected].

Region

NSW, QLD, TAS, VIC

Further details

Full details of the trial can be found on the ANZCTR clinical trials database: http://www.ANZCTR.org.au/ACTRN12619000765123.aspx

Ethics Approval

Yes

Last updated

18/10/2019

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