Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Diet
Brief summary
The purpose of this study is to evaluate if following a specific low fat diet will improve the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.
Detailed description
This research project has significance for its potential to develop a new therapeutic approach to MS. Current treatments in MS include disease modifying therapies such as human recombinant interferon beta, glatiramer acetate and natalizumab. However, these are only partially effective, cannot be taken orally, have side-effects and are very expensive. Developing treatment that can be combined with current disease modifying agent remains an important goal for improving the care of people with MS.
Interventions
OTHERLow fat study diet
The low fat study diet is a very low-saturated-fat, plant food based diet. It will be approximately 10% fat, 14% protein and 76% carbohydrate.The diet is is starched based and also contains fresh or frozen fruits and vegetables and there is no animal meat used, including no use of fish. This diet is very low in saturated fats and enriched in unsaturated fats. Subjects do not take dietary supplements.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of the relapsing-remitting form of MS * Age 18-70, inclusive * MS duration of less than 15 years * May or may not be on disease-modifying therapies for MS, but if on, must be on for more than 6 months of continuous therapy * Should not have diabetes * Able and willing to follow exercise instructions * Able and willing to travel to California for 10-day training program (cost covered by study) * Able and willing to travel to Portland, OR for 6 study visits over the 12 month study period (cost covered by study)
Exclusion criteria
* No clinically significant MS exacerbation within 30 days of screening visit * No systemically administered corticosteroids within 30 days of study entry * Patient not pregnant or breastfeeding * Not taking fish oil/flax seed for at least 2 months prior to first visit * No other significant health programs (e.g. active coronary heart disease, liver disease, pulmonary disease) that might increase risk of patient experiencing adverse events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet. | Baseline. Month 12. |
Secondary
| Measure | Time frame |
|---|---|
| To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life. | Baseline. Month 3. Month 6. Month 9. Month 12. |
| To study the effects of the Low Fat Study Diet on serum markers of inflammation | Baseline. Month 6. Month 12. |
| To assess safety and tolerability of the low fat study diet upon 12 months of administration | Baseline. Month 3. Month 6. Month 9. Month 12. |
Countries
United States
Outcome results
None listed