Low Fat Diet for Fatigue in MS | NCT03322982

NCT03322982

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
National Multiple Sclerosis Society	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MS Diet	Experimental	34 people with MS following low-fat diet	Behavioral: Low-fat diet
MS Wait-List	No Intervention	34 people with MS following usual diet
Diet Healthy Control	No Intervention	20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group
Wait-List Healthy Control	No Intervention	20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group

Name	Type	Description	Arm Group Labels	Other Names
Low-fat diet	Behavioral	less than 20% calories from fat daily	MS Diet

Outcomes Module

Primary Outcomes

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 Outcomes

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

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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Anna Orban	Contact	503-494-3549		orban@ohsu.edu

Name	Affiliation	Role
Vijayshree Yadav	Oregon Health and Science University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health Science University	Recruiting	Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37941305	Derived	Chase E, Chen V, Martin K, Lane M, Wooliscroft L, Adams C, Rice J, Silbermann E, Hollen C, Fryman A, Purnell JQ, Vong C, Orban A, Horgan A, Khan A, Srikanth P, Yadav V. A low-fat diet improves fatigue in multiple sclerosis: Results from a randomized controlled trial. Mult Scler. 2023 Nov;29(13):1659-1675. doi: 10.1177/13524585231208330.

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D009103	Multiple Sclerosis

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Intervention Browse Module

ID	Term
D018752	Diet, Fat-Restricted

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

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.