Low Fat Diet for Fatigue in MS

NCT ID: NCT03322982

Last Updated: 2021-03-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.

Study Groups

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MS Diet

34 people with MS following low-fat diet

Group Type EXPERIMENTAL

Low-fat diet

Intervention Type BEHAVIORAL

less than 20% calories from fat daily

MS Wait-List

34 people with MS following usual diet

Group Type NO_INTERVENTION

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

Group Type NO_INTERVENTION

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low-fat diet

less than 20% calories from fat daily

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Vijayshree Yadav

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Orban

Role: CONTACT

503-494-3549

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.

Reference Type DERIVED
PMID: 37941305 (View on PubMed)

Other Identifiers

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OHSU IRB16600

Identifier Type: -

Identifier Source: org_study_id

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