Wahls Paleo Diet and Progressive Multiple Sclerosis

NCT01915433 | Completed

• 1 other identifier: 201302829
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis; Relapsing progressive multiple sclerosis; relapsing remitting multiple sclerosis; Fatigue; Quality of life; Paleo; Nutrition; Ketogenic

Outcome Measures

Primary Outcomes (1)

• Perceived Fatigue

  Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale

  Baseline, weeks, 4,8 and 12

Secondary Outcomes (21)

• Biomarkers

  Baseline and 12 weeks

• Biomarkers - glucose and ketones

  Baseline and at 4, 8, 12 weeks

• 24 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)

Study Arms (3)

Wahls Paleo Plus

EXPERIMENTAL

Wahls Paleo Plus diet (ketogenic diet)

Other: Wahls Paleo Plus

Wahls Diet

EXPERIMENTAL

Wahls Diet (modified paleolithic diet)

Other: Wahls Diet

Usual Care

NO INTERVENTION

Control - usual care only.

Interventions

Wahls Paleo Plus OTHER

The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low in carbohydrate and high in fat but still ensure consumption of the specific micronutrients important to optimal brain function. This diet is designed to induce a low level nutritional ketosis.

Also known as: Wahls Paleo Plus (ketogenic diet)

Wahls Paleo Plus

Wahls Diet OTHER

The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low glycemic diet and also ensure consumption of the specific micronutrients important to optimal brain function.

Also known as: Wahls Diet (modified paleolithic diet)

Wahls Diet

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Secondary or Primary Progressive MS, relapsing progressive MS, relapsing- remitting MS
• Generally able to walk 25 feet in less than 60 seconds;
• 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.
• age between 30 and including 65 at entry into the RUN IN study,
• non smoker,
• willingness to be randomized
• Mild gait disability as shown by an EDSS score of 4.5 or higher
• Confirmed MS diagnosis using McDonald criteria
• Eating standard American diet.

You may not qualify if:

• change in medication in the prior 90 days, taking anti-platelet or anticoagulant therapy therapy, or having a major psychiatric disorder making compliance difficult,
• SELF REPORTED history of current diagnosis of diabetes, or active liver, kidney or clinically significant heart disease,
• unable to record daily weight at home,
• eating a vegetarian diet or chronic diarrhea, have already adopted a Paleo Diet (as defined by a complete elimination of grain, dairy, and legumes)
• unable to cope with 30% in grocery bill,
• Alanine aminotransferase value \> 2X normal, or elevated creatinine value, (main study only)
• incompetence.
• Too low or too high BMI.
• 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.
• aversion to coconut milk
• \) 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.

Sponsors & Collaborators

• Terry L. Wahls: lead

Study Sites (2)

Univeristy of Iowa

Iowa City, Iowa, 52240, United States

Location

Univeristy of Iowa

Iowa City, Iowa, 52246, United States

Location

Related Publications (9)

• 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.

  PMID: 21138391 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.

  PMID: 19918474 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.

  PMID: 21253878 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.

  PMID: 21827937 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.

  PMID: 17066210 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.

  PMID: 17066209 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.

  PMID: 22205763 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.

  PMID: 19209185 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.

  PMID: 22509165 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Fatigue

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Terry L Wahls, MD

  University of Iowa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: November 1, 2016
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)