Recruiting

Low Fat Diet

Sponsor:

Oregon Health and Science University

Code:

NCT03322982

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Low-fat diet

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT03322982

Start date

Aug 15, 2018

Status verified date

Feb, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MS Diet

34 people with MS following low-fat diet

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

Interventions

Low-fat diet

less than 20% calories from fat daily

Primary outcome measure

  • Fatigue [ Time Frame: Baseline to month 4 ]

Central Contacts and Locations

Central contacts

Anna Orban

503-494-3549orban@ohsu.edu

Locations

Oregon Health Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Oregon Health and Science University

Last update posted

Mar 1, 2021

Last verified

Feb, 2021

Keywords

  • diet, low-fat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2021-03-01.