Introduction – Direct-MS is very pleased to be funding a rigorous clinical trial which will test the effectiveness of the Direct-MS recommended nutritional strategies, often referred to as the Best Bet Diet for MS (BBD), for affecting MS disease activity. Such research is of critical importance for determining if the recommended nutritional strategies are of value for MS and thus worth serious consideration as a therapeutic option. Recruitment for the trial began in July, 2006 and it is hoped that results will be available early in 2008.

Leaders – The chief investigator of the clinical research is Dr Jonathan O’Riordan, Consultant Neurologist and Director of Tayside MS Regional Service and Research Unit, Ninewells Hospital, Dundee, Scotland. The principle investigator and study doctor is Dr. Pushkar S. Shah, Registrar and Research Fellow, MS Research Unit, Dept. of Neurology, Ninewells Hospital, Dundee. The MS Research Coordinator is Mrs. Sally Wilson also of Ninewells Hospital.

Ethics – The study has been approved by the Ethics Board of Ninewells Hospital. It will be conducted in accordance the European Clinical Trials Directive and associated guidelines, the International Conference on Harmonization Guidelines on Good Clinical Practice and the Principles of the Declaration of Helsinki, as well as all other national and local laws and regulations.

Goal – The main goal of the study is to compare the effectiveness of the Best Bet Diet for MS (BBD) with that of the dietary advice provided by the MS Society of Britain for decreasing MS disease activity over one year of use.

Methods – The study will involve 30 participants, all of whom have relapsing-remitting MS and EDSS disability between 0 and 3.5. Fifteen participants will be randomly assigned to the BBD and the other 15 to the dietary advice of the MS Society.

The study will last one year and each participant will have an MRI scan at baseline, 2 months, 4 months, 6 months and at 1 year. The MRI scans will measure T1 and T2 lesions as well as brain volume.

The participants will also have a complete physical and neurological examination at baseline, 6 months and 1 year. At these times disability will be measured using the EDSS (Expanded Disability Status Scale) and MSFC (MS Functional Composite) scales.

At baseline and every 4 weeks the participants will complete questionnaires including a Fatigue Severity Scale (FSS), MS Quality of Life Inventory (MSQLI) and Patient Global Assessment (PGA).

Monitoring Dietary Compliance – The participants will complete food diaries every 3 months and, in-between the visits to the clinic, subjects will be given reminders via phone and letters. They will also have daily access to the research unit for dietary advice.

Results – The effects on MS disease activity after one year will be assessed through the measured changes in disability scores, brain volume and lesion load. An assessment of symptom control and quality of life will be obtained from the completed questionnaires. The various results from those participants on the BBD will be statistically compared with the results from those following the dietary advice of the MS Society to determine if the BBD has a measurable positive effect on MS disease activity.

Discussion – This clinical trial is basically a “Phase I/II” trial and will determine if the BBD has a measurable effect on MS disease activity and if such dietary research can be accomplished in a scientifically acceptable manner. If positive results are obtained, a larger trial, involving up to 100 participants in each arm, will be necessary to confirm the positive effect of the BBD and to allow a better assessment of the strength of that effect.

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