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 (ISRCTN: 69897291). 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 -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.

CONCLUSION: A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.