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

<jats:p>The impact of flavonoids on fatigue has not been investigated in relapsing and remitting multiple sclerosis (RRMS).</jats:p><jats:sec><jats:title>Objective</jats:title><jats:p>To determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley, UK (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="isrctn" xlink:href="69897291">ISRCTN69897291</jats:ext-link>). During a 6-week intervention participants consumed a high or low flavonoid cocoa beverage daily. Fatigue and fatigability were measured at three visits (weeks 0, 3 and 6). Feasibility and fidelity were assessed through recruitment and retention, adherence and a process evaluation.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>40 people with multiple sclerosis (10 men, 30 women, age 44±10 years) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data were &lt;20% and adherence to intervention of allocated individuals was &gt;75%. There was a small effect on fatigue (Neuro-QoL: effect size (ES) 0.04, 95% CI −0.40 to 0.48) and a moderate effect on fatigability (6 min walk test: ES 0.45, 95% CI −0.18 to 1.07). There were seven adverse events (four control, three intervention), only one of which was possibly related and it was resolved.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.</jats:p></jats:sec>