Feasibility trial: pure cocoa to improve fatigue in pwMS
Research type
Research Study
Full title
A feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with Relapsing and Remitting Multiple Sclerosis (RRMS).
IRAS ID
199515
Contact name
Hazel Abbott
Contact email
Sponsor organisation
Oxford Brookes University
ISRCTN Number
ISRCTN69897291
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background: Fatigue is one of the most common and debilitating symptoms for people with Multiple Sclerosis (pwMS). Flavonoid-rich foods such as cocoa are becoming increasingly recognised for their potential to improve factors such as inflammation and oxidative stress which can worsen fatigue. However, a systematic search of PubMed found no intervention trial assessing the effect of flavonoid supplementation for improving fatigue in pwMS. The aim of this study is therefore to explore the potential of a flavonoid-rich cocoa drink for improving fatigue in pwMS. Methods: This will be a randomised controlled feasibility study involving 40 pwMS. Outcome measures will include measures of fatigue, assessment of dietary patterns and activity levels, and blood markers that may help to explain any effects that we see. With the results from this trial, the feasibility and the potential of using a flavonoid rich cocoa intervention for improving fatigue in pwMS will be assessed. The results from this feasibility study will be used to assess the need for performing a fully powered trial.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0134
Date of REC Opinion
30 Mar 2016
REC opinion
Further Information Favourable Opinion