Low Fat Diet and Multiple Sclerosis (MS)
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|ClinicalTrials.gov Identifier: NCT00852722|
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Low fat study diet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Study of Diet and Multiple Sclerosis|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: 1. Low fat study diet
The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet.
Other: Low 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.
No Intervention: 2. Regular diet group
The regular diet arm will be a wait-listed group that will receive no training in diet and will be advised to continue their regular (usual) diet as was prior to entry into the study, for the duration of the study. They will have a similar clinic follow up schedule as the treatment group. The regular diet group will be given identical instructions to exercise regularly similar to the treatment group.
- 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. [ Time Frame: Baseline. Month 12. ]
- 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. [ Time Frame: Baseline. Month 3. Month 6. Month 9. Month 12. ]
- To study the effects of the Low Fat Study Diet on serum markers of inflammation [ Time Frame: Baseline. Month 6. Month 12. ]
- To assess safety and tolerability of the low fat study diet upon 12 months of administration [ Time Frame: Baseline. Month 3. Month 6. Month 9. Month 12. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852722
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Vijayshree Yadav, MD||Oregon Health and Science University|