Wahls Paleo Diet and Progressive Multiple Sclerosis

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

Interventions

OTHER

Wahls Paleo Plus

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.

OTHER

Wahls Diet

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.

Sponsors & Collaborators

• Terry L. Wahls

  lead OTHER

Principal Investigators

• Terry L Wahls, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2014-02-28

Completion

2016-11-30

Countries

• United States

Study Locations