Low Fat Diet and Multiple Sclerosis

NCT ID: NCT00852722

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-07-31

Brief Summary

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.

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low fat study diet

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Vijayshree Yadav

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vijayshree Yadav, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Related Links

http://www.ohsu.edu/ms

MS Center of OHSU website

Other Identifiers

OHSU IRB00004555

Identifier Type: -

Identifier Source: org_study_id