Journal Article


A randomised double blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with Relapsing and Remitting Multiple Sclerosis

Abstract

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 (ISRCTN: 69897291). During a six 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 pwMS (10 men, 30 women, age 44 ± 10 yrs) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data was <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size {ES} 0.04; confidence interval {CI} -0.40-0.48) and a moderate effect on fatigability (six-minute walk test: ES 0.45; CI -0.18 - 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.

Attached files

Authors

Coe, Shelly
Cossington, Jo
Collett, Johnny
Soundy, Andrew
Izadi, Hooshang
Ovington, Martin
Durkin, Luke
Kirsten, Maja
Clegg, Miriam
Cavey, Ana
Wade, Derick T.
Palace, Jacqueline
DeLuca, Gabriele C.
Chapman, Kim
Harrison, John M.
Buckingham, Elizabeth
Dawes, Helen

Oxford Brookes departments

Faculty of Health and Life Sciences\Department of Sport, Health Sciences and Social Work

Dates

Year of publication: 2019
Date of RADAR deposit: 2019-01-30


Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License


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