Low Fat Diet and Multiple Sclerosis - Full Text View

Sponsor:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00852722

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Controlled Study of Diet and Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Diets Multiple Sclerosis

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 and 12 months ] [ 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, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
To study the effects of the Low Fat Study Diet on serum markers of inflammation [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
To assess safety and tolerability of the low fat study diet upon 12 months of administration [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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: 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.

Arms

Assigned Interventions

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

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: 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.

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 10 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 be diabetic
Able and willing to follow exercise instructions
Able and willing to travel to California for training program

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

Contacts

Contact: Lauren E Stuber, BS	503-494-3549	stuberl@ohsu.edu
Contact: Geoff Winder, BA	503-494-0174	winderg@ohsu.edu

Locations

United States, Oregon
Oregon Health and Science University	Recruiting
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:	Oregon Health and Science University ( Vijayshree Yadav )
Study ID Numbers:	OHSU IRB00004555
Study First Received:	February 26, 2009
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00852722 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Multiple sclerosis
Diet

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 30, 2009