title: Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.
abstract: BACKGROUND
  The role that dietary interventions can play in multiple sclerosis (MS) management is of huge interest amongst patients and researchers but data evaluating this is limited. Possible effects of a very-low-fat, plant-based dietary intervention on MS related progression and disease activity as measured by brain imaging and MS related symptoms have not been evaluated in a randomized-controlled trial. Despite use of disease modifying therapies (DMT), poor quality of life (QOL) in MS patients can be a significant problem with fatigue being one of the common disabling symptoms. Effective treatment options for fatigue remain limited. Emerging evidence suggests diet and vascular risk factors including obesity and hyperlipidemia may influence MS disease progression and improve QOL.
  
  
  OBJECTIVE
  To evaluate adherence, safety and effects of a very-low-fat, plant-based diet (Diet) on brain MRI, clinical [MS relapses and disability, body mass index (BMI)] and metabolic (blood lipids and insulin) outcomes, QOL [Short Form-36 (SF-36)], and fatigue [Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS)], in relapsing-remitting MS (RRMS).
  
  
  METHODS
  This was a randomized-controlled, assessor-blinded, one-year long study with 61 participants assigned to either Diet (N=32) or wait-listed (Control, N=29) group.
  
  
  RESULTS
  The mean age (years) [Control-40.9±8.48; Diet-40.8±8.86] and the mean disease duration (years) [Control -5.3±3.86; Diet-5.33±3.63] were comparable between the two groups. There was a slight difference between the two study groups in the baseline mean expanded disability status scale (EDSS) score [Control-2.22±0.90; Diet-2.72±1.05]. Eight subjects withdrew (Diet, N=6; Control, N=2). Adherence to the study diet based on monthly Food Frequency Questionnaire (FFQ) was excellent with the diet group showing significant difference in the total fat caloric intake compared to the control group [total fat intake/total calories averaged ~15% (Diet) versus ~40% (Control)]. The two groups showed no differences in brain MRI outcomes, number of MS relapses or disability at 12 months. The diet group showed improvements at six months in low-density lipoprotein cholesterol (Δ=-11.99mg/dL; p=0.031), total cholesterol (Δ=-13.18mg/dL; p=0.027) and insulin (Δ=-2.82mg/dL; p=0.0067), mean monthly reductions in BMI (Rate=-1.125kg/m2 per month; p<0.001) and fatigue [FSS (Rate=-0.0639 points/month; p=0.0010); MFIS (Rate=-0.233 points/month; p=0.0011)] during the 12-month period.
  
  
  CONCLUSIONS
  While a very-low fat, plant-based diet was well adhered to and tolerated, it resulted in no significant improvement on brain MRI, relapse rate or disability as assessed by EDSS scores in subjects with RRMS over one year. The diet group however showed significant improvements in measures of fatigue, BMI and metabolic biomarkers. The study was powered to detect only very large effects on MRI activity so smaller but clinically meaningful effects cannot be excluded. The diet intervention resulted in a beneficial effect on the self-reported outcome of fatigue but these results should be interpreted cautiously as a wait-list control group may not completely control for a placebo effect and there was a baseline imbalance on fatigue scores between the groups. If maintained, the improved lipid profile and BMI could yield long-term vascular health benefits. Longer studies with larger sample sizes are needed to better understand the long-term health benefits of this diet.
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA. Electronic address: yadavv@ohsu.edu.
authors.forename: Vijayshree
authors.initials: V
authors.lastname: Yadav
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.
authors.forename: Gail
authors.initials: G
authors.lastname: Marracci
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Kim
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Spain
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Cameron
authors.affiliation: Novant Medical Group, Charlotte, NC, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Overs
authors.affiliation: MS/MRI Research Group, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Riddehough
authors.affiliation: MS/MRI Research Group, University of British Columbia, Vancouver, BC, Canada.
authors.forename: David K B
authors.initials: DK
authors.lastname: Li
authors.affiliation: The McDougall Research and Education Foundation, Santa Rosa, CA, USA.
authors.forename: John
authors.initials: J
authors.lastname: McDougall
authors.affiliation: Department of Neurology, Louisiana State University, New Orleans, LA, USA.
authors.forename: Jesus
authors.initials: J
authors.lastname: Lovera
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Murchison
authors.affiliation: Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Bourdette
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001921:Brain / Q000000981:diagnostic imaging; D002784:Cholesterol / Q000097:blood; D018752:Diet, Fat-Restricted / Q000009:adverse effects / Q000379:methods*; D004185:Disability Evaluation; D005221:Fatigue / Q000000981:diagnostic imaging / Q000178:diet therapy / Q000378:metabolism; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000000981:diagnostic imaging / Q000178:diet therapy* / Q000378:metabolism / Q000523:psychology; D010349:Patient Compliance; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007328:Insulin; D002784:Cholesterol
keywords: Diet; Fatigue; Low fat; Magnetic resonance imaging; Multiple sclerosis