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Research paper
A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis
  1. Shelly Coe1,
  2. Jo Cossington1,
  3. Johnny Collett1,
  4. Andrew Soundy2,
  5. Hooshang Izadi1,
  6. Martin Ovington1,
  7. Luke Durkin1,
  8. Maja Kirsten1,
  9. Miriam Clegg3,
  10. Ana Cavey4,
  11. Derick T Wade1,
  12. Jacqueline Palace2,
  13. Gabriele C DeLuca2,
  14. Kim Chapman1,
  15. Jane-Marie Harrison1,
  16. Elizabeth Buckingham1,
  17. Helen Dawes1
  1. 1 Department of Sport Health Sciences and Social Work, Centre for Movement Occupational and Rehabilitation Sciences, Oxford Brookes Centre for Nutrition and Health, Oxford Brookes Univeristy, Oxford, UK
  2. 2 Department of Neurology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
  3. 3 Department of Food and Nutritional Sciences, University of Reading, Reading, UK
  4. 4 University of Birmingham, Birmingham, UK
  1. Correspondence to Dr Shelly Coe, Department of Sport Health Sciences and Social Work, Centre for Movement Occupational and Rehabilitation Sciences, Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP, UK; scoe{at}brookes.ac.uk

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, 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 −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.

  • fatigue
  • cocoa
  • diet
  • multiple sclerosis
  • flavonoids

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Footnotes

  • Contributors SC, JC, AS, MC, AC, STW, JP, GD, JMH, EB and HD were involved in the design and ongoing conduct of the project. SC and HD were responsible for the overall conduct of the project. JC, JC, AS, LD, MK, and HD were responsible for the data collection and day to day running of the trial. HI was involved in the stastical analysis of the project. All authors were involved in the writing and proof reading of the project. Wade was responsible for AEs.

  • Funding Funding for the trial was granted from the Multiple Sclerosis Society; Grant reference 32. HD is funded by Elizabeth Casson Trust and Higher Education Thames Valley and the Biomedical Research Centres. JC is funded by Heath Education Thames Valley. Disclosure funding for highly specialised services to run a national congenital myasthenia service and a neuromyelitis service. Support for scientific meetings and honorariums for advisory work from Merck Serono, Biogen Idec, Novartis, Teva, Abide, Chugai Pharma, Alexion, MedDay, Argenx and Bayer Schering, Medimmune and unrestricted grants from Merck Serono, Novartis, Biogen Idec, Chugai, Alexion and Bayer Schering. MS society and Guthie Jackson Foundation research grants.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval was granted from the National Research Ethics Service {Solihull West Midlands reference: 199515).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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