A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis
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A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis. / 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, Jane-Marie; Buckingham, Elizabeth; Dawes, Helen.
In: J NEUROL NEUROSUR PS, Vol. 90, No. 5, 05.2019, p. 507-513.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis
AU - Coe, Shelly
AU - Cossington, Jo
AU - Collett, Johnny
AU - Soundy, Andrew
AU - Izadi, Hooshang
AU - Ovington, Martin
AU - Durkin, Luke
AU - Kirsten, Maja
AU - Clegg, Miriam
AU - Cavey, Ana
AU - Wade, Derick T
AU - Palace, Jacqueline
AU - DeLuca, Gabriele C
AU - Chapman, Kim
AU - Harrison, Jane-Marie
AU - Buckingham, Elizabeth
AU - Dawes, Helen
N1 - © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/5
Y1 - 2019/5
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1136/jnnp-2018- 319496
DO - 10.1136/jnnp-2018- 319496
M3 - SCORING: Journal article
C2 - 30833449
VL - 90
SP - 507
EP - 513
JO - J NEUROL NEUROSUR PS
JF - J NEUROL NEUROSUR PS
SN - 0022-3050
IS - 5
ER -