Low Fat Diet and Multiple Sclerosis (MS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Low fat study diet

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Vijayshree Yadav, MD, Oregon Health and Science University

Publications and helpful links

Helpful Links

• MS Center of OHSU website

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Diet
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: OHSU IRB00004555