Back to resultsLow Fat Diet for Fatigue in MS
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat diet
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring diet, low-fat
Eligibility 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
Sites / Locations
- Oregon Health Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
No Intervention
No Intervention
Arm Label
MS Diet
MS Wait-List
Diet Healthy Control
Wait-List Healthy Control
Arm Description
34 people with MS following low-fat diet
34 people with MS following usual diet
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03322982
First Posted
October 24, 2017
Last Updated
February 25, 2021
Sponsor
Oregon Health and Science University
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03322982
Brief Title
Low Fat Diet for Fatigue in MS
Official Title
A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Multiple Sclerosis Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
diet, low-fat
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team.
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MS Diet
Arm Type
Experimental
Arm Description
34 people with MS following low-fat diet
Arm Title
MS Wait-List
Arm Type
No Intervention
Arm Description
34 people with MS following usual diet
Arm Title
Diet Healthy Control
Arm Type
No Intervention
Arm Description
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group
Arm Title
Wait-List Healthy Control
Arm Type
No Intervention
Arm Description
20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group
Intervention Type
Behavioral
Intervention Name(s)
Low-fat diet
Intervention Description
less than 20% calories from fat daily
Primary Outcome Measure Information:
Title
Fatigue
Description
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
Time Frame
Baseline to month 4
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
Baseline to month 4
Title
Disability
Description
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.
Time Frame
Baseline to month 4
Other Pre-specified Outcome Measures:
Title
Microbiome- Relative abundance of targeted species of gut microflora
Description
Measured by 16S rRNA sequencing
Time Frame
Baseline to month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Orban
Phone
503-494-3549
Email
orban@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijayshree Yadav
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijayshree Yadav
12. IPD Sharing Statement
Plan to Share IPD
No
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Low Fat Diet for Fatigue in MS
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