A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Oregon Health and Science University
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Fatigue
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Vijayshree Yadav
Associate Professor of Neurology
Oregon Health and Science University
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Fatigue
Time Frame: Baseline to month 4
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
Secondary Outcomes
- Fatigue(Baseline to month 4)
- Disability(Baseline to month 4)