A study to determine whether the daily consumption of flavonoid-rich p
A 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)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
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
Thinking and memoryFatigueWalking and mobility
Other measures (1)
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
Physical functionMood and sleepQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 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: 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of symptoms including problems with balance and coordination and weakness in the arms or legs. One of the most common symptoms of MS is fatigue (extreme tiredness), affecting around 80% of sufferers. Pure cocoa may have the ability to improve fatigue because it contains substances called flavonoids. Flavanoids are becoming increasingly recognized for their potential to improve bodily processes which can worsen fatigue due to its antioxidant properties. However to date, no well-designed studies have looked at the role of cocoa consumption for fatigue management in people with MS. The aim of this study is to find out whether a flavonoid-rich cocoa drink is an effective means of improving fatigue in people with MS. Who can participate? Adults diagnosed with relapsing-remitting MS (RRMS) within the last 5 years who are experiencing fatigue What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group are asked to drink a hot flavonoid-rich pure cocoa drink every morning for six weeks. Those in the second group are asked to drink a hot low flavonoid pure cocoa drink every morning for six weeks. At the start of the study and again after three and six weeks, participants in both groups completes a number of questionnaires and physical assessments in order to find out if their fatigue has improved. Participants also provide a blood sample at these times so that the level of glutathione (a chemical indicator of antioxidant status) can be measured. What are the possible benefits and risks of participating? It is currently unknown whether there will be any direct benefits to those taking part in the study. There is a small risk of pain or bruising during and after blood testing. Where is the study run from? 1. Oxford Brookes University (UK) 2. John Radcliffe Hospital, Oxford (UK) When is the study starting and how long is it expected to run for? January 2016 to December 2017 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Dr Shelly Coe scoe@brookes.ac.uk
Papers
Results
A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis.J Neurol Neurosurg Psychiatry · 2019
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History
Started
May 2016
Finished
Oct 2017