Text Size

Low Fat Diet and Multiple Sclerosis (MS)

This study is ongoing, but not recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Other: Low fat study diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of Diet and Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome 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. [ Time Frame: Baseline. Month 12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 61
Study Start Date: February 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852722

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
  More Information

Additional Information:
MS Center of OHSU website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vijayshree Yadav, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00852722     History of Changes
Other Study ID Numbers: OHSU IRB00004555
Study First Received: February 26, 2009
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Multiple sclerosis
Diet

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013