Low Fat Diet and Multiple Sclerosis
A Randomized, Controlled Study of Diet and Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Low fat study diet
What it measured
Main measures
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.
MRI lesions
Other measures (3)
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.
Disability progressionRelapsesFatigueMood and sleepQuality of life (reported by participants)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.
Safety
Who could take part
Relapsing MS · 18 to 70
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2009
Main results due
Jul 2014
Finished
Jul 2014