NCT03322982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

October 24, 2017

Last Update Submit

February 25, 2021

Conditions

Multiple Sclerosis

Keywords

diet, low-fat

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    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

    Baseline to month 4

Secondary Outcomes (2)

  • Fatigue

    Baseline to month 4

  • Disability

    Baseline to month 4

Other Outcomes (1)

  • Microbiome- Relative abundance of targeted species of gut microflora

    Baseline to month 4

Study Arms (4)

MS Diet

EXPERIMENTAL

34 people with MS following low-fat diet

Behavioral: Low-fat diet

MS Wait-List

NO INTERVENTION

34 people with MS following usual diet

Diet Healthy Control

NO INTERVENTION

20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group

Wait-List Healthy Control

NO INTERVENTION

20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group

Interventions

Low-fat dietBEHAVIORAL

less than 20% calories from fat daily

MS Diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70
  • Diagnosis of MS by 2010 McDonald Criteria
  • EDSS ≤ 7.5
  • Experiencing moderate to severe fatigue (MFIS ≥ 38)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37941305DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Vijayshree Yadav

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Orban

CONTACT

503-494-3549orban@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 26, 2017

Study Start

August 15, 2018

Primary Completion

September 30, 2021

Study Completion

March 31, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)