TY - JOUR
T1 - Low-fat, plant-based diet in multiple sclerosis
T2 - 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
N1 - Funding Information:
V. Yadav has served as a section editor for Current Neurology and Neuroscience Reports , as consultant for Bayer Healthcare Pharmaceutical, Teva Neurosciences, Biogen Idec, on the speakers’ bureau of Novartis, and received research support from the McDougall Foundation, NIH, National Multiple Sclerosis Society (NMSS) Foundation, Nancy Davis Center Without Walls Foundation, and Biogen Idec.
Funding Information:
R. Spain has received research support from the Veterans Affairs (VA) RR&D Service, NMSS, and the Medical Research Foundation of Oregon; and has received honoraria from the NMSS and the MS Society of Portland.
Funding Information:
M. Cameron has received research support from the US Department of VA, the NMSS, the Collins Foundation, Acorda Therapeutics, and the Multiple Sclerosis International Federation; has served as a consultant for Acorda Therapeutics and Adamas Pharmaceuticals; has received funding for travel from the Consortium of MS Centers (CMSC), the Paralyzed Veterans of America and the NMSS, and honoraria from Genzyme Corporation, DJO Global, the MS Association of America, the MS Society of Portland, and CMSC.
Funding Information:
D. K. B. Li has received research funding from the Canadian Institute of Health Research and Multiple Sclerosis Society of Canada. He is the Director of the UBC MS/MRI Research Group which has been contracted to perform central analysis of MRI scans for therapeutic trials with Genzyme, Hoffmann-LaRoche, Merck-Serono, Nuron Biotech, Parexel and Sanofi-Aventis. He has also acted as a consultant to Vertex Pharmaceuticals and served on the Data and Safety Advisory Board for Opexa Therapeutics and Scientific Advisory Boards for Novartis, Nuron and Roche.
Funding Information:
J. Lovera has received research support from NIH, the NMSS, and LaCats.
Funding Information:
D. Bourdette has received speaker honoraria and consulting fees from Biogen Idec and Teva Neurosciences, consulting fees from Elan Pharmaceuticals, speaker honoraria from Genzyme, and research grants from the US Department of VA, NIH and NMSS.
PY - 2016/9/1
Y1 - 2016/9/1
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=−11.99 mg/dL; p=0.031), total cholesterol (Δ=−13.18 mg/dL; p=0.027) and insulin (Δ=−2.82 mg/dL; p=0.0067), mean monthly reductions in BMI (Rate=−1.125 kg/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.
AB - 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=−11.99 mg/dL; p=0.031), total cholesterol (Δ=−13.18 mg/dL; p=0.027) and insulin (Δ=−2.82 mg/dL; p=0.0067), mean monthly reductions in BMI (Rate=−1.125 kg/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.
KW - Diet
KW - Fatigue
KW - Low fat
KW - Magnetic resonance imaging
KW - Multiple sclerosis
UR - http://www.scopus.com/inward/record.url?scp=84978708508&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84978708508&partnerID=8YFLogxK
U2 - 10.1016/j.msard.2016.07.001
DO - 10.1016/j.msard.2016.07.001
M3 - Article
C2 - 27645350
AN - SCOPUS:84978708508
VL - 9
SP - 80
EP - 90
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
SN - 2211-0348
ER -