Low Fat Diet for Fatigue in MS
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03322982 |
Recruitment Status :
Recruiting
First Posted : October 26, 2017
Last Update Posted : April 13, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Behavioral: Low-fat diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Diet adherence assessments will be conducted by blinded assessors from OHSU bionutrition team. |
Primary Purpose: | Other |
Official Title: | A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis |
Actual Study Start Date : | August 15, 2018 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | March 31, 2021 |

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
|
- Fatigue [ Time Frame: Baseline to month 4 ]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
- Fatigue [ Time Frame: Baseline to month 4 ]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 [ Time Frame: Baseline to month 4 ]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.
- Microbiome- Relative abundance of targeted species of gut microflora [ Time Frame: Baseline to month 4 ]Measured by 16S rRNA sequencing

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322982
Contact: Anna Orban | 503-494-3549 | orban@ohsu.edu |
United States, Oregon | |
Oregon Health Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Vijayshree Yadav |
Principal Investigator: | Vijayshree Yadav | Oregon Health and Science University |
Responsible Party: | Vijayshree Yadav, Associate Professor of Neurology, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT03322982 |
Other Study ID Numbers: |
OHSU IRB16600 |
First Posted: | October 26, 2017 Key Record Dates |
Last Update Posted: | April 13, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
diet, low-fat |
Multiple Sclerosis Sclerosis Fatigue Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |