A study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing remitting multiple sclerosis (RRMS)

Not Applicable

Completed

• Conditions: Specialty: Neurological disorders, Primary sub-specialty: Multiple sclerosis; UKCRC code/ Disease: Neurological/ Systemic atrophies primarily affecting the central nervous system; Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN69897291
• Lead Sponsor: Oxford Brookes University

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29403649 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30833449 [added 07/03/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-06
• Study Completion: 2017-10-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18 years and over
2. New (<10 year) clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
3. Treatment naïve or taking first line DMTs - glatiramer acetate, interferone beta, teriflunomide and
dimethyl furmarate
4. Willing to comply to consuming the cocoa drink;
5. A fatigue measure of greater than 4 on the Fatigue Severity Scale (FSS)
6. An Expanded Disability Status Scale (EDSS) score of < 4.5;
7. Able to walk with or without a walker for at least 16 meters (length of the 6 minute walk test);

Exclusion Criteria

1. Those experiencing a relapse or sudden change in their MS symptoms within the previous three months
2. Conditions affecting the central nervous system other than MS (excluding migraines)
3. Contraindications to providing a blood sample
4. Any other conditions that may be associated with fatigue, e.g. anaemia
5. On medication for the treatment of depression
6. Pregnant or lactating
7. Insufficient mental capacity to consent
8. Objection to contacting their GP and clinicians
9. Currently taking part in another drug trial or expected change in medication during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Fatigue is measured using a numerical rating scale (NRS) at baseline and three times daily for six weeks<br> 2. Fatigability is measured using a 6 minute walk test and The Adult Memory and Information Processing Battery (AMIBP) at baseline, 3 and 6 weeks<br>