A study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing remitting multiple sclerosis (RRMS)

Conditions

Specialty: Neurological disorders, Primary sub-specialty: Multiple sclerosis

Maedeh Mansoubi, Susan G. Coe, Jo Cossington, Johnny Collet, Miriam Clegg et al. (10 authors)

Translational Medicine and Exercise Prescription2021-06-222 citations

10.53941/tmep.v1i1.36

A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis

Susan G. Coe, Jo Cossington, Johnny Collett, Andrew Soundy, Hooshang Izadi et al. (17 authors)

Journal of Neurology Neurosurgery & Psychiatry2019-03-0428 citations

10.1136/jnnp-2018-319496

A protocol for a randomised double-blind placebo-controlled feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing and remitting multiple sclerosis (RRMS)

Susan G. Coe, Johnny Collett, H. Izadi, Derick T Wade, Miriam Clegg et al. (11 authors)

Pilot and Feasibility Studies2018-01-226 citations

10.1186/s40814-018-0230-7

Interventions

Following provision of informed consent and study screening, eligible participants complete a baseline assessment and are randomly allocated to either the high flavonoid cocoa intervention group or th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over 2. New (<10 year) clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS) 3. Treatment naïve or taking first line DMTs - glatiramer acetate, interferone beta, teriflunomide and dimethyl furmarate 4. Willing to comply to consuming the cocoa drink; 5. A fatigue measure of greater than 4 on the Fatigue Severity Scale (FSS) 6. An Expanded Disability Status Scale (EDSS) score of < 4.5; 7. Able to walk with or without a walker for at least 16 meters (length of the 6 minute walk test);

Exclusion criteria

Exclusion criteria: 1. Those experiencing a relapse or sudden change in their MS symptoms within the previous three months 2. Conditions affecting the central nervous system other than MS (excluding migraines) 3. Contraindications to providing a blood sample 4. Any other conditions that may be associated with fatigue, e.g. anaemia 5. On medication for the treatment of depression 6. Pregnant or lactating 7. Insufficient mental capacity to consent 8. Objection to contacting their GP and clinicians 9. Currently taking part in another drug trial or expected change in medication during the trial

Design outcomes

Primary

Measure	Time frame
1. Fatigue is measured using a numerical rating scale (NRS) at baseline and three times daily for six weeks 2. Fatigability is measured using a 6 minute walk test and The Adult Memory and Information Processing Battery (AMIBP) at baseline, 3 and 6 weeks	—

Secondary

Measure	Time frame
1. Compliance to the intervention is determined through measuring blood glutathione levels at baseline, 3 and 6 weeks 2. Levels of physical activity are measured using wearable activity monitors (worn like a watch) for a total of 17 days (3 days prior to trial, week 3 and week 6) and The Physical Activity Scale for the Elderly (PASE) questionnaire at baseline, 3 and 6 weeks 3. Dietary patterns are measured using a 3-day 24-hour food record at baseline, 3 and 6 weeks 4. Inflammation is measured by testing blood TNF-alpha and lipid peroxidation levels at baseline, 3 and 6 weeks 5. Quality of life is measured using EQ5D5L at baseline, 3 and 6 weeks 6. Health related quality of life specific to MS is measured using the Preference-Based Multiple Sclerosis Index (PBMSI) at baseline, 3 and 6 weeks 7. Demographics and basic health information are measured using the basic health questionnaire at baseline, 3 and 6 weeks 8. Limitations in daily activity is measured using the Barthels Index (BI) at baseline, 3 and 6 weeks 9. Anxiety and Depression are measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 3 and 6 weeks	—

Measure

Time frame

1. Compliance to the intervention is determined through measuring blood glutathione levels at baseline, 3 and 6 weeks 2. Levels of physical activity are measured using wearable activity monitors (worn like a watch) for a total of 17 days (3 days prior to trial, week 3 and week 6) and The Physical Activity Scale for the Elderly (PASE) questionnaire at baseline, 3 and 6 weeks 3. Dietary patterns are measured using a 3-day 24-hour food record at baseline, 3 and 6 weeks 4. Inflammation is measured by testing blood TNF-alpha and lipid peroxidation levels at baseline, 3 and 6 weeks 5. Quality of life is measured using EQ5D5L at baseline, 3 and 6 weeks 6. Health related quality of life specific to MS is measured using the Preference-Based Multiple Sclerosis Index (PBMSI) at baseline, 3 and 6 weeks 7. Demographics and basic health information are measured using the basic health questionnaire at baseline, 3 and 6 weeks 8. Limitations in daily activity is measured using the Barthels Index (BI) at baseline, 3 and 6 weeks 9. Anxiety and Depression are measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 3 and 6 weeks

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Countries

United Kingdom

Contacts

Public ContactShelly Coe

scoe@brookes.ac.uk+44 (0)1865 483988

Outcome results

None listed