Low Fat Diet for Fatigue in MS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Low-fat diet

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Orban; Phone Number: 503-494-3549; Email: orban@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health Science University
      • Contact: Vijayshree Yadav

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MS Diet; 34 people with MS following low-fat diet	Behavioral: Low-fat diet; less than 20% calories from fat daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Measured by Fatigue Severity Scale (FSS). The FSS is a 9-item questionnaire, with subjects giving a response from 1-7 to indicate their degree of agreement with each statement.	Baseline to month 4
Disability	Measured by EDSS. The EDSS is an eight functional system scale including motor, sensory, cerebellar, brain stem, visual, mental, sphincteric, and other systems. Each functional system is graded from 0 (no disability) to 5 or 6 (maximal disability)20. An integrated score between 0 (normal examination) and 10 (death from MS) is formed based on the score in each functional system.	Baseline to month 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome- Relative abundance of targeted species of gut microflora	Measured by 16S rRNA sequencing	Baseline to month 4

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: Vijayshree Yadav, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: diet, low-fat
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: OHSU IRB16600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No