| February 26, 2009 |
| February 26, 2009 |
| February 2009 |
| March 2011 (final data collection date for primary outcome measure) |
| 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 and 12 months ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- 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, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
- To study the effects of the Low Fat Study Diet on serum markers of inflammation [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
- To assess safety and tolerability of the low fat study diet upon 12 months of administration [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Low Fat Diet and Multiple Sclerosis |
| A Randomized, Controlled Study of Diet and Multiple Sclerosis |
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. |
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. |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Multiple Sclerosis |
| Other: Low fat study diet |
- Experimental: The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet.
- No Intervention: 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.
|
| |
| |
| Recruiting |
| 54 |
| March 2012 |
| March 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical diagnosis of the relapsing-remitting form of MS
- Age 18-70, inclusive
- MS duration of less than 10 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 be diabetic
- Able and willing to follow exercise instructions
- Able and willing to travel to California for training program
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
|
| Both |
| 18 Years to 70 Years |
| No |
|
|
| United States |
| |
| NCT00852722 |
| Vijayshree Yadav, Oregon Health and Science University |
| OHSU IRB00004555 |
| Oregon Health and Science University |
|
| Principal Investigator: |
Vijayshree Yadav, MD |
Oregon Health and Science University |
|
|
| Oregon Health and Science University |
| February 2009 |