Multiple Sclerosis
Conditions
Keywords
diet, low-fat
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.
Interventions
BEHAVIORALLow-fat diet
less than 20% calories from fat daily
Sponsors
National Multiple Sclerosis Society
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline to month 4 | 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. |
| Disability | Baseline to month 4 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiome- Relative abundance of targeted species of gut microflora | Baseline to month 4 | Measured by 16S rRNA sequencing |
Countries
United States
Contacts
Primary ContactAnna Orban
Outcome results
None listed