Low Fat Diet for Fatigue in MS

Study Overview
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Brief Summary
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A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.

Official Title
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A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Low-fat diet


Participation Criteria
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Eligibility Criteria
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For participants with MS: Inclusion Criteria: Age 18-70 Diagnosis of MS by 2010 McDonald Criteria EDSS ≤ 7.5 Experiencing moderate to severe fatigue (MFIS ≥ 38) Exclusion Criteria: Current cardiopulmonary disease requiring treatment Diabetes Pregnancy or breast-feeding MS exacerbation within 30 days of screening visit IV steroids within 30 days of screening visit Dietary fat content of <30% as assessed by food frequency questionnaire (FFQ) at screening visit Fish oil or flax seed oil supplementation within 30 days of screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS Diet<br>34 people with MS following low-fat diet | Behavioral: Low-fat diet<br>* less than 20% calories from fat daily<br>|
| No Intervention: MS Wait-List<br>34 people with MS following usual diet | |
| No Intervention: Diet Healthy Control<br>20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group | |
| No Intervention: Wait-List Healthy Control<br>20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Measured by Modified Fatigue Impact Scale (MFIS). The MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of > 38 are considered to experience moderate to severe fatigue | Baseline to month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Measured by Fatigue Severity Scale (FSS). The FSS is a 9-item questionnaire, with subjects giving a response from 1-7 to indicate their degree of agreement with each statement. | Baseline to month 4 | 
| Disability | Measured by EDSS. The EDSS is an eight functional system scale including motor, sensory, cerebellar, brain stem, visual, mental, sphincteric, and other systems. Each functional system is graded from 0 (no disability) to 5 or 6 (maximal disability)20. An integrated score between 0 (normal examination) and 10 (death from MS) is formed based on the score in each functional system. | Baseline to month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, low-fat