Low Fat Diet for Fatigue in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03322982
• Other study ID #: OHSU IRB16600
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2021
• Source: Oregon Health and Science University
• Contact: Anna Orban
• Phone: 503-494-3549
• Email: orban[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: March 31, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Low-fat diet
less than 20% calories from fat daily

Locations

Country	Name	City	State
United States	Oregon Health Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiome- Relative abundance of targeted species of gut microflora	Measured by 16S rRNA sequencing	Baseline to month 4
Primary	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	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
Secondary	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