A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT03322982

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Low-fat diet

What it measured

Main measures

  • Fatigue

    Baseline to month 4

    Fatigue

Other measures (2)

  • Fatigue

    Baseline to month 4

    Fatigue
  • Disability

    Baseline to month 4

    Disability progression

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Aug 2018

    2. Main results due

      Sept 2021

    3. Finished

      Mar 2022

    Assembled by software from public sources.