Wahls Paleo Diet and Progressive Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT01915433
- Lead Sponsor
- Terry L. Wahls
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Perceived Fatigue Baseline, weeks, 4,8 and 12 Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
- Secondary Outcome Measures
Name Time Method Biomarkers - glucose and ketones Baseline and at 4, 8, 12 weeks GLucose, insulin, ketones, hemoglobin a1c to assess insulin sensitivity. Full intervention at baseline, and weeks 4,8,12 Minimal intervention at baseline and week 12.
MS functional composite score. Baseline and end of study (12 weeks) This a composite of tests involving tests of walking, hand coordination and mental addition.
Medical symptoms quest. (MSQ) Baseline, weekly through week 12 Scored review of systems questionaire
Life spaces score Baseline and week 12 Questions about the locations subjects has been in the prior time period of interest.
Health questions baseline A list of questions to identify common medical comorbid conditions and their severity if present.
MS Quality of Life (MSQoli 54) Baseline, week 12 MS Qoli 54 is a series of questions about physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
Daily Food logs Baseline through end of study (12 weeks) This is a record of daily food and beverage consumption. The two intervention groups will keep the record daily. The usual care group will keep the a food record the initial two weeks and for two weeks between weeks 10 and 12.
Medication audit Baseline List of currently used medications, vitamins, supplements and over the counter medications.
Functional Medicine assessment summary Baseline or 12 weeks A series of questions about a number of environmental risk factors for development of neurological and medical symptoms. Completed prior to orientation to study intervention diet after randomization (intervention groups) or at 12 weeks for usual care group.
MS Function Scale baseline and week 12 A series of questions about the tasks of daily life.
Expanded disability status score Baseline and 12 weeks Assessment of disability status
Biomarkers Baseline and 12 weeks Biomarkers include weight, Body Mass Index,and blood biomarkers of renal and liver function, vitamin levels (A,C,K,D, B vitamins), homocysteine, h.s. c- reactive protein (CRP)
MS Quality of life inventory (MSQLI) Baseline and week 12 MSQLI is a series of questions asking about daily life. Includes physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
Veteran Specific Activity Quest. Baseline and 12 weeks. Series of questions about the tasks of daily life to identify how much activity the individual can safely do.
24 hr food recalls. Baseline and 12 weeks The 24 hr recalls will be collected at baseline in in the last 4 weeks of study. This will include nutrient analyses as well.
6 minute walk test Baseline and week 12 Subject will walk 6 minutes. They may rest as needed during the 6 minute time period. The total length of time that is walked will be recorded.
Satiety scale Baseline and weeks 10 and 11 A series of questions about the sense of satiety or sense of fullness.
Physical examination baseline and 12 weeks Summary of physical findings from physical examination.
Demographic data Baseline and week 12 Questions about demographic attributes such as race, education, handedness.
Harvard Food Frequency Quest. Baseline A series of questions about the frequency of a variety of foodstuffs to estimate nutrient intake.
Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation Baseline and week 12 Brachial artery FMD and endothelium-independent dilation will be determined non-invasively using high-resolution ultrasonography.
Trial Locations
- Locations (1)
Univeristy of Iowa
🇺🇸Iowa City, Iowa, United States
Univeristy of Iowa🇺🇸Iowa City, Iowa, United States