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Posted: Fri Sep 22, 2006 4:56 pm Post subject: DIRECT-MS funding a clinical trial to test the Best Bet Diet
Testing the Effectiveness of the Best Bet Diet for Decreasing Disease Activity in Multiple Sclerosis
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).
Best Bet Diet Nutritional Protocol –
Eat fruits and vegetables for carbohydrates and micro-nutrients
Eat fish and skinless breast of chicken and turkey, for protein
Eat extra virgin olive oil for fats
Avoid all dairy, grains (except rice), legumes
Avoid all allergenic foods, which are identified by skin and ELISA tests.
Avoid all red meat and margarine
Supplements:
1. Grape seed extract 2 capsules/day
2. VitaminD3 2000 IU/day in summer and 4000 IU/day in winter
3. Calcium 1200 mg/day
4. Vitamin A 5000 IU/day
5. 10 grams salmon oil
6. Vitamin B-complex 50 mg/day
7. 500 mcg of B-12
8. 1 g of vitamin C
9. 400 IU of vitamin E
10. up to 750 mg of magnesium (a good Ca/Mg ratio is 2:1)
11. 25 mg of zinc
12. 1 mg of copper
13. 200 mcg of selenium
14. Manganese 20 mg/day
15. up to 5 g of evening primrose oil or borage oil
16. 4 capsules of acidophilus
17. 4 capsules of enzymes
18. 500 - 1000 mg of Lecithin.
19. Ginkgo biloba 120 mg/day
20. Co-enzyme Q10 60 mg/day.
MS Society of Britain Dietary Advice –
1. Five portions of fruit or vegetables everyday including one portion of dark green, leafy vegetables.
2. Use polyunsaturated margarine and oils such as sunflower oil or corn oil, instead of saturated fat such as lard and butter.
3. Grill, Bake, steam or poach food instead of frying.
4. Choose lean cuts of meat. Avoid sausages, pates and beefburgers, as they are often high in saturated fat.
5. Avoid too much saturated fat and hydrogenated vegetable oil in foods like pastry, cakes and chocolate.
6. Eat at least two portions of fish a week, one of which should be oily fish like mackerel, pilchards, salmon or sardines.
7. Use low fat dairy products such as skimmed milk, low-fat yoghurt or low fat cheeses.
8. Eat whole meal bread and whole grain cereals.
9. Drink six to eight cups of fluid daily (about 1.5 litres). Don’t rely on high-caffeine drinks, such as coffee, tea and cola.
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.
The lead researchers are currently assessing the MRI data from the trial but this is the abstract that was used for the ECTRIMS2008 conference this September.
Cheers
Nick
Title: Analysis of dietary intervention in early relapsing remitting MS
Background: Epidemiological studies suggest that dietary factors may influence risk of MS. There is high usage of complementary therapies amongst MS patients, and in particular various dietary modifications are popular. There is currently no significant trial data regarding dietary interventions in MS.
Objectives: Assess effect of dietary intervention, in particular the Best Bet Diet (BBD) on disease progression in early relapsing remitting MS.
Methods: Patients with diagnosis of relapsing remitting MS by MacDonald’s criteria with EDSS score of ≤ 3.5 were randomised to one of the two study diets (BBD and the diet advised by the MS society of UK) for a period of 12 months. The assessor was blinded to the treatments. EDSS scores, MSFC scores, Body mass index (BMI) and volumetric MRI brain were assessed at baseline and 6 monthly. Fatigue severity scales and visual analogue scales (VAS) were monitored. Subjects completed 7 day food diaries every 3 months.
Results: 28 patients consented, and 22 completed the trial. There were no adverse effects in any groups. There was no significant difference in BMI at baseline and at 12 months in either group. There was trend of lower rate of brain atrophy and change in EDSS in group on Best bet Diet but this was not statistically significant. MSFC score was significantly better in Best Bet Diet group (P: 0.0465), with difference of means at 2.08. There was significant improvement in VAS in BBD group (P: 0.046).
Conclusions: Dietary factors may be important in MS pathology. A hypoallergenic diet with high dose Vit D3 and fish oils, such as the BBD may have a role in slowing disease progression in MS.
Authors:
Pushkar S Shah
Louise Gold
Jonathan I O’Riordan
Nick's comment
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test).
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