Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2018-08-15
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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MS Diet
34 people with MS following low-fat diet
Low-fat diet
less than 20% calories from fat daily
MS Wait-List
34 people with MS following usual diet
No interventions assigned to this group
Diet Healthy Control
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group
No interventions assigned to this group
Wait-List Healthy Control
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group
No interventions assigned to this group
Interventions
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Low-fat diet
less than 20% calories from fat daily
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of MS by 2010 McDonald Criteria
* EDSS ≤ 7.5
* Experiencing moderate to severe fatigue (MFIS ≥ 38)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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National Multiple Sclerosis Society
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Vijayshree Yadav
Associate Professor of Neurology
Principal Investigators
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Vijayshree Yadav
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Vijayshree Yadav
Role: primary
References
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Chase E, Chen V, Martin K, Lane M, Wooliscroft L, Adams C, Rice J, Silbermann E, Hollen C, Fryman A, Purnell JQ, Vong C, Orban A, Horgan A, Khan A, Srikanth P, Yadav V. A low-fat diet improves fatigue in multiple sclerosis: Results from a randomized controlled trial. Mult Scler. 2023 Nov;29(13):1659-1675. doi: 10.1177/13524585231208330.
Other Identifiers
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OHSU IRB16600
Identifier Type: -
Identifier Source: org_study_id
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