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

Phase 2

Completed

• Conditions: Multiple Sclerosis; Fatigue; Neurological - Multiple sclerosis

• Registration Number: ACTRN12619000765123
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-22
• Study Completion: 2023-09-26
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 117

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

•Recent relapse of multiple sclerosis with onset within 12 weeks of recruitment interview
•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 events: 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 >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 > 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 or no access to computer/tablet or phone;
•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)
•Participant cannot be involved in any other interventional trial or study during the study period
•Any other reason that the investigator team deems the individual to not be suitable for participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified