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

The impact of flavonoids on fatigue has not been investigated in relapsing and remitting multiple sclerosis (RRMS). Objective To determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS. Methods A randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley, UK (ISRCTN69897291). 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. Results 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 <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size (ES) 0.04, 95% CI â '0.40 to 0.48) and a moderate effect on fatigability (6 min walk test: ES 0.45, 95% CI â '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. Conclusion A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.