Low Fat Diet and Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MS  

Official title:

A Randomized, Controlled Study of Diet and Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852722
• Other study ID #: OHSU IRB00004555
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2009
• Last updated: February 2, 2015
• Start date: February 2009
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	To study the effects of the Low Fat Study Diet on serum markers of inflammation		Baseline. Month 6. Month 12.	No
Secondary	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.	Yes