Low Fat Diet and Multiple Sclerosis

NCT00852722 | Completed Phase 1 DMC

• 1 other identifier: OHSU IRB00004555
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

1. Low fat study diet

EXPERIMENTAL

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

2. Regular diet group

NO INTERVENTION

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.

Interventions

Low fat study diet 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.

1. Low fat study diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Links

• MS Center of OHSU website

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vijayshree Yadav, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)