Evidence map›Paper›PMID 29403649›Full record

ArticlePilot and feasibility studies2018

A protocol for a randomised double-blind placebo-controlled 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).

S Coe, J Collett, H Izadi, D T Wade, M Clegg, J M Harrison, E Buckingham, A Cavey, G C DeLuca, J Palace and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

S Coe1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
J Collett1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
H Izadi3School of Engineering, Computing and Mathematics, Faculty of Technology, Design and Environment, Oxford Brookes University, Wheatley Campus, Room R2.32, Oxford, OX33 1HX UK.
D T Wade1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
M Clegg1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
J M Harrison1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
E Buckingham1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
A Cavey2Department of Neurology, Nuffield Department of Clinical Neuroscienes, University of Oxford, Oxford, OX3 9DU UK.
G C DeLuca2Department of Neurology, Nuffield Department of Clinical Neuroscienes, University of Oxford, Oxford, OX3 9DU UK.
J Palace2Department of Neurology, Nuffield Department of Clinical Neuroscienes, University of Oxford, Oxford, OX3 9DU UK.
H Dawes1Centre for Movement and Occupational Rehabilitation Sciences, Oxford Institute of Midwifery, Nursing and Allied Health Research, and Oxford Brookes Centre for Nutrition and Health, Oxford Brookes University, Oxford, OX30BP UK.
Oxford Brookes University · GBUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDietary interventions including consumption of flavonoids, plant compounds found in certain foods, may have the ability to improve fatigue. However, to date, no well-designed intervention studies assessing the role of flavonoid consumption for fatigue management in people with MS (pwMS) have been performed. The hypothesis is that the consumption of a flavonoid-rich pure cocoa beverage will reduce fatigue in pwMS. The aim of this study is to determine the feasibility and potential outcome of running a trial to evaluate this hypothesis.

methodsUsing a randomised (1:1) double-blind placebo-controlled feasibility study, 40 men and women (20 in each trial arm) with a recent diagnosis (< 10 years) of relapsing and remitting MS (RRMS) and who are over 18 years of age will be recruited from neurology clinics and throughout the Thames Valley community. During a 6-week nutrition intervention period, participants will consume the cocoa beverage, high flavonoid or low flavonoid content, at breakfast daily. At baseline, demographic factors and disease-related factors will be assessed. Fatigue, activity and quality of life, in addition to other measures, will be taken at three visits (baseline, week 3 and week 6) in a university setting by a researcher blinded to group membership. Feasibility and fidelity will be assessed through recruitment and retention, adherence and a quantitative process evaluation at the end of the trial.We will describe demographic factors (age, gender, level of education) as well as disease-related factors (disease burden scores, length of time diagnosed with MS) and cognitive assessment, depression and quality of life and general physical activity in order to characterise participants and determine possible mediators to identify the processes by which the intervention may bring about change. Feasibility (recruitment, safety, feasibility of implementation of the intervention and evaluation, protocol adherence and data completion) and potential for benefit (estimates of effect size and variability) will be determined to inform future planned studies. Results will be presented using point estimates, 95% confidence intervals and DISCUSSION: We propose that a flavonoid-enriched cocoa beverage for the management of fatigue will be well received by participants. Further, if it is implemented early in the disease course of people diagnosed with RRMS, it will improve mobility and functioning by modifying fatigue.

trial registrationRegistered with ISRCTN Registry. Trial registration No: ISRCTN69897291; Date April 2016.

Indexed as

CocoaDietFatigueFlavonoidsMultiple sclerosis

Identifiers

PMID29403649
PMCPMC5778802
OpenAlexW2790143604

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.