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Low Fat Diet for Fatigue in MS

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ClinicalTrials.gov Identifier: NCT03322982
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Low-fat diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.
Primary Purpose: Other
Official Title: A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MS Diet
34 people with MS following low-fat diet
 Behavioral: Low-fat diet
less than 20% calories from fat daily
No Intervention: MS Wait-List
34 people with MS following usual diet
No Intervention: Diet Healthy Control
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group
No Intervention: Wait-List Healthy Control
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Fatigue [ Time Frame: 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.

  2. Disability [ Time Frame: 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 Outcome Measures:
  1. Microbiome- Relative abundance of targeted species of gut microflora [ Time Frame: Baseline to month 4 ]
    Measured by 16S rRNA sequencing


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322982


Contacts
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Contact: Anna Orban 503-494-3549 orban@ohsu.edu

Locations
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United States, Oregon
Oregon Health Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Vijayshree Yadav         
Sponsors and Collaborators
Oregon Health and Science University
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Vijayshree Yadav Oregon Health and Science University
More Information
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Responsible Party: Vijayshree Yadav, Associate Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03322982    
Other Study ID Numbers: OHSU IRB16600
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vijayshree Yadav, Oregon Health and Science University:
diet, low-fat
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases