Back to results

Low Fat Diet and Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Low fat study diet

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1. Low fat study diet

2. Regular diet group

Arm Description

The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet.

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.

Outcomes

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.

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.

To study the effects of the Low Fat Study Diet on serum markers of inflammation

To assess safety and tolerability of the low fat study diet upon 12 months of administration

Full Information

NCT ID

NCT00852722

First Posted

February 26, 2009

Last Updated

February 2, 2015

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT00852722

Brief Title

Low Fat Diet and Multiple Sclerosis

Acronym

Official Title

A Randomized, Controlled Study of Diet and Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple sclerosis, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Low fat study diet

Arm Type

Experimental

Arm Description

The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet.

Arm Title

2. Regular diet group

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Low fat study diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

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. Month 12.

Secondary Outcome Measure Information:

Title

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. Month 3. Month 6. Month 9. Month 12.

Title

To study the effects of the Low Fat Study Diet on serum markers of inflammation

Time Frame

Baseline. Month 6. Month 12.

Title

To assess safety and tolerability of the low fat study diet upon 12 months of administration

Time Frame

Baseline. Month 3. Month 6. Month 9. Month 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vijayshree Yadav, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.ohsu.edu/ms

Description

MS Center of OHSU website

Learn more about this trial

Low Fat Diet and Multiple Sclerosis

We'll reach out to this number within 24 hrs