Low Fat Diet for Fatigue in MS

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Low-fat diet

• Registration Number: NCT03322982
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-26
• Study Start: 2018-08-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MS Diet	Low-fat diet	34 people with MS following low-fat diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oregon Health Science University; 🇺🇸 Portland, Oregon, United States