Wahls Paleo Diet and Progressive Multiple Sclerosis
Wahls Paleo Diet and Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Wahls Paleo Plus
- Wahls Diet
What it measured
Main measures
Perceived Fatigue
Baseline, weeks, 4,8 and 12
Fatigue
Other measures (21)
Biomarkers
Baseline and 12 weeks
Blood or spinal fluid markersBiomarkers - glucose and ketones
Baseline and at 4, 8, 12 weeks
Blood or spinal fluid markers24 hr food recalls.
Baseline and 12 weeks
Daily Food logs
Baseline through end of study (12 weeks)
MS functional composite score.
Baseline and end of study (12 weeks)
Walking and mobility6 minute walk test
Baseline and week 12
Walking and mobilityMedical symptoms quest. (MSQ)
Baseline, weekly through week 12
Life spaces score
Baseline and week 12
Medication audit
Baseline
Physical examination
baseline and 12 weeks
Who could take part
Relapsing and progressive · 30 to 65
Show the full criteria
Inclusion criteria
Inclusion Criteria - to complete 2 week RUN IN to determine eligibility for Main Study: Inclusion Criteria - 1. Secondary or Primary Progressive MS, relapsing progressive MS, relapsing- remitting MS 2. Generally able to walk 25 feet in less than 60 seconds; 3. significant fatigue as documented by a fatigue severity scale score of 4 or more OR a modified fatigue impact scale score of 38 or higher. 4. age between 30 and including 65 at entry into the RUN IN study, 5. non smoker, 6. willingness to be randomized 7. Mild gait disability as shown by an EDSS score of 4.5 or higher 8. Confirmed MS diagnosis using McDonald criteria 9. Eating standard American diet. Exclusion Criteria for RUN IN to determine eligibility: 1. change in medication in the prior 90 days, taking anti-platelet or anticoagulant therapy therapy, or having a major psychiatric disorder making compliance difficult, 2. SELF REPORTED history of current diagnosis of diabetes, or active liver, kidney or clinically significant heart disease, 3. unable to record daily weight at home, 4. eating a vegetarian diet or chronic diarrhea, have already adopted a Paleo Diet (as defined by a complete elimination of grain, dairy, and legumes) 5. unable to cope with 30% in grocery bill, 6. Alanine aminotransferase value > 2X normal, or elevated creatinine value, (main study only) 7. incompetence. 8. Too low or too high BMI. 9. Inability to follow study diet, which requires shopping carefully and food preparation, by either the study subject or with the help of an adult companion to do the shopping and food preparation. 10. aversion to coconut milk Main Study Inclusion Criteria 1) Successful completion of RUN IN Study - which means, the subject completed the various quest. and survey documents that are part of the RUN-IN study, completed the food diary for each day they participated in the RUN-IN, the subject is eating the standard American Diet as documented by the daily food logs and the 24 hour dietary recalls.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in biomarkers than the usual care group experiences at 12 weeks. The usual care group will be given instruction in following both the wahls paleo plus and the wahls diet plans and how to utilize the daily food logs at the end of study visit. The usual care group will receive one nutrition coaching call to assist with implementation of the study diet.
Papers
Results
A Modified MCT-Based Ketogenic Diet Increases Plasma β-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study.J Am Coll Nutr · 2021
Background
Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.Background
Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601.Background
Wahls TL. The seventy percent solution. J Gen Intern Med. 2011 Oct;26(10):1215-6. doi: 10.1007/s11606-010-1631-3. No abstract available.Background
Riccio P. The molecular basis of nutritional intervention in multiple sclerosis: a narrative review. Complement Ther Med. 2011 Aug;19(4):228-37. doi: 10.1016/j.ctim.2011.06.006. Epub 2011 Jul 27.Background
Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 2 : macronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):386-99.Background
Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 1: micronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):377-85.Background
Bowman GL, Silbert LC, Howieson D, Dodge HH, Traber MG, Frei B, Kaye JA, Shannon J, Quinn JF. Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging. Neurology. 2012 Jan 24;78(4):241-9. doi: 10.1212/WNL.0b013e3182436598. Epub 2011 Dec 28.Background
Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.Background
Stafstrom CE, Rho JM. The ketogenic diet as a treatment paradigm for diverse neurological disorders. Front Pharmacol. 2012 Apr 9;3:59. doi: 10.3389/fphar.2012.00059. eCollection 2012.
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History
Started
Jul 2013
Main results due
Feb 2014
Finished
Nov 2016