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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.

OBJECTIVES

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.

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  • Authors+Show Affiliations

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    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.

    ,

    Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.

    ,

    Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.

    ,

    Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.

    ,

    Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.

    ,

    Novant Medical Group, Charlotte, NC, USA.

    ,

    MS/MRI Research Group, University of British Columbia, Vancouver, BC, Canada.

    ,

    MS/MRI Research Group, University of British Columbia, Vancouver, BC, Canada.

    ,

    The McDougall Research and Education Foundation, Santa Rosa, CA, USA.

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    Department of Neurology, Louisiana State University, New Orleans, LA, USA.

    ,

    Department of Neurology, Oregon Health & Science University, USA.

    Department of Neurology, Oregon Health & Science University, USA; Department of Veterans Affairs MS Center of Excellence-West, Portland, OR, USA.

    Source

    MeSH

    Adolescent
    Adult
    Aged
    Body Mass Index
    Brain
    Cholesterol
    Diet, Fat-Restricted
    Disability Evaluation
    Fatigue
    Female
    Humans
    Insulin
    Male
    Middle Aged
    Multiple Sclerosis, Relapsing-Remitting
    Patient Compliance
    Quality of Life
    Severity of Illness Index
    Single-Blind Method
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    27645350

    Citation

    Yadav, Vijayshree, et al. "Low-fat, Plant-based Diet in Multiple Sclerosis: a Randomized Controlled Trial." Multiple Sclerosis and Related Disorders, vol. 9, 2016, pp. 80-90.
    Yadav V, Marracci G, Kim E, et al. Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2016;9:80-90.
    Yadav, V., Marracci, G., Kim, E., Spain, R., Cameron, M., Overs, S., ... Bourdette, D. (2016). Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial. Multiple Sclerosis and Related Disorders, 9, pp. 80-90. doi:10.1016/j.msard.2016.07.001.
    Yadav V, et al. Low-fat, Plant-based Diet in Multiple Sclerosis: a Randomized Controlled Trial. Mult Scler Relat Disord. 2016;9:80-90. PubMed PMID: 27645350.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial. AU - Yadav,Vijayshree, AU - Marracci,Gail, AU - Kim,Edward, AU - Spain,Rebecca, AU - Cameron,Michelle, AU - Overs,Shannon, AU - Riddehough,Andrew, AU - Li,David K B, AU - McDougall,John, AU - Lovera,Jesus, AU - Murchison,Charles, AU - Bourdette,Dennis, Y1 - 2016/07/06/ PY - 2015/11/30/received PY - 2016/06/28/revised PY - 2016/07/01/accepted PY - 2016/9/21/entrez PY - 2016/9/21/pubmed PY - 2017/3/1/medline KW - Diet KW - Fatigue KW - Low fat KW - Magnetic resonance imaging KW - Multiple sclerosis SP - 80 EP - 90 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 9 N2 - 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. OBJECTIVES: 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. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/27645350/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(16)30100-6 DB - PRIME DP - Unbound Medicine ER -