Wahls Paleo Diet and Progressive Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 6/28/2018 |
| Start Date: | July 2013 |
| End Date: | November 2016 |
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.
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.
Specific Aim 1. To assess changes in fatigue severity (primary outcome measure) and quality
of life, motor, cognitive and emotional functions (secondary measures) the intervention
groups (wahls paleo plus and wahls diet group)to usual care.
Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more
improvements in quality of life and fatigue between baseline and 12 weeks than usual care
group.
Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of
life and fatigue than the wahls diet group.
Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the
subject progresses through the study interventions.
Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable
changes in blood biomarkers obtained at baseline and week 12 than the usual care group.
Hypothesis 2b: The wahls paleo plus group will demonstrate more favorable changes in blood
biomarkers and quality of life than the wahls diet group experiences obtained at baseline and
week 12.
Hypothesis 2c: The wahls paleo plus and the wahls diet group will demonstrate more favorable
changes in measures of endothelial function between baseline and week 12 than will be
observed in the usual care group.
Hypothesis 2d: The wahls paleo plus will demonstrate more favorable changes in measures of
endothelial function between baseline and week 12 than the wahls diet group.
of life, motor, cognitive and emotional functions (secondary measures) the intervention
groups (wahls paleo plus and wahls diet group)to usual care.
Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more
improvements in quality of life and fatigue between baseline and 12 weeks than usual care
group.
Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of
life and fatigue than the wahls diet group.
Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the
subject progresses through the study interventions.
Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable
changes in blood biomarkers obtained at baseline and week 12 than the usual care group.
Hypothesis 2b: The wahls paleo plus group will demonstrate more favorable changes in blood
biomarkers and quality of life than the wahls diet group experiences obtained at baseline and
week 12.
Hypothesis 2c: The wahls paleo plus and the wahls diet group will demonstrate more favorable
changes in measures of endothelial function between baseline and week 12 than will be
observed in the usual care group.
Hypothesis 2d: The wahls paleo plus will demonstrate more favorable changes in measures of
endothelial function between baseline and week 12 than the wahls diet group.
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.
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