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Clinical Trials/NCT03322982
NCT03322982UnknownNot Applicable

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

Oregon Health and Science University2 sites in 1 country108 target enrollmentStarted: August 15, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
108
Locations
2
Primary Endpoint
Fatigue
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
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 Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vijayshree Yadav

Associate Professor of Neurology

Oregon Health and Science University

Study Sites (2)

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Low Fat Diet for Fatigue in MS | Clinical Trial