Low Fat Diet and Multiple Sclerosis (MS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00852722
First received: February 26, 2009
Last updated: October 29, 2012
Last verified: October 2012

February 26, 2009
October 29, 2012
February 2009
March 2013   (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. Month 12. ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00852722 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • To study the effects of the Low Fat Study Diet on serum markers of inflammation [ Time Frame: Baseline. Month 6. Month 12. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
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.
  • 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.
    Intervention: Other: Low fat study diet
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
61
March 2013
March 2013   (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 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852722
OHSU IRB00004555
Yes
Vijayshree Yadav, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
Oregon Health and Science University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP