Low Fat Diet for Fatigue in MS

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Behavioral: Low-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03322982

OHSU IRB16600

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 4 patient groups

MS Diet

Experimental group

Description:

34 people with MS following low-fat diet

Treatment:

Behavioral: Low-fat diet

MS Wait-List

No Intervention group

Description:

34 people with MS following usual diet

Diet Healthy Control

No Intervention group

Description:

20 controls with no diagnosis of MS, age and sex-matched to members of the MS Diet group

Wait-List Healthy Control

No Intervention group

Description:

20 controls with no diagnosis of MS, age and sex-matched to members of the MS Wait-List group