Clinical trial NCT01915433: Wahls Paleo Diet and Progressive Multiple Sclerosis
Official title: Wahls Paleo Diet and Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Perceived Fatigue
timeFrame: Baseline, weeks, 4,8 and 12
Secondary outcomes:
measure: Biomarkers
timeFrame: Baseline and 12 weeks
measure: Biomarkers - glucose and ketones
timeFrame: Baseline and at 4, 8, 12 weeks
measure: 24 hr food recalls.
timeFrame: Baseline and 12 weeks
measure: Daily Food logs
timeFrame: Baseline through end of study (12 weeks)
measure: MS functional composite score.
timeFrame: Baseline and end of study (12 weeks)
measure: 6 minute walk test
timeFrame: Baseline and week 12
measure: Medical symptoms quest. (MSQ)
timeFrame: Baseline, weekly through week 12
measure: Life spaces score
timeFrame: Baseline and week 12
measure: Medication audit
timeFrame: Baseline
measure: Physical examination
timeFrame: baseline and 12 weeks
measure: Health questions
timeFrame: baseline
measure: MS Quality of Life (MSQoli 54)
timeFrame: Baseline, week 12
measure: MS Quality of life inventory (MSQLI)
timeFrame: Baseline and week 12
measure: Demographic data
timeFrame: Baseline and week 12
measure: Functional Medicine assessment summary
timeFrame: Baseline or 12 weeks
measure: Veteran Specific Activity Quest.
timeFrame: Baseline and 12 weeks.
measure: MS Function Scale
timeFrame: baseline and week 12
measure: Satiety scale
timeFrame: Baseline and weeks 10 and 11
measure: Harvard Food Frequency Quest.
timeFrame: Baseline
measure: Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation
timeFrame: Baseline and week 12
measure: Expanded disability status score
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Univeristy of Iowa
state: Iowa
city: Iowa City
country: United States
facility: Univeristy of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Terry L Wahls, MD
role: STUDY_DIRECTOR
References:
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