Wahls Paleo Diet and Progressive Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01915433
First received: July 25, 2013
Last updated: February 11, 2014
Last verified: February 2014

July 25, 2013
February 11, 2014
July 2013
September 2014   (final data collection date for primary outcome measure)
Perceived Fatigue [ Time Frame: Baseline, weeks, 4,8 and 12 ] [ Designated as safety issue: No ]
Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
  • Fatigue [ Time Frame: Time 0 through 12 weeks ] [ Designated as safety issue: No ]
    Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
  • Quality of life [ Time Frame: Time zero through 12 weeks ] [ Designated as safety issue: No ]
    quality of life as measured by the MS Qoli 54 (MS quality of life 54) and the MSQLI (MS quality of life inventory) which 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. Also life spaces, medical symptoms questionnaire.
Complete list of historical versions of study NCT01915433 on ClinicalTrials.gov Archive Site
  • Biomarkers [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    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)
  • Biomarkers - glucose and ketones [ Time Frame: Baseline and at 4, 8, 12 weeks ] [ Designated as safety issue: No ]
    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.
  • 24 hr food recalls. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The 24 hr recalls will be collected at baseline in in the last 4 weeks of study. This will include nutrient analyses as well.
  • Daily Food logs [ Time Frame: Baseline through end of study (12 weeks) ] [ Designated as safety issue: No ]
    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.
  • MS functional composite score. [ Time Frame: Baseline and end of study (12 weeks) ] [ Designated as safety issue: No ]
    This a composite of tests involving tests of walking, hand coordination and mental addition.
  • 6 minute walk test [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.
  • Medical symptoms quest. (MSQ) [ Time Frame: Baseline, weekly through week 12 ] [ Designated as safety issue: No ]
    Scored review of systems questionaire
  • Life spaces score [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    Questions about the locations subjects has been in the prior time period of interest.
  • Medication audit [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    List of currently used medications, vitamins, supplements and over the counter medications.
  • Physical examination [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Summary of physical findings from physical examination.
  • Health questions [ Time Frame: baseline ] [ Designated as safety issue: No ]
    A list of questions to identify common medical comorbid conditions and their severity if present.
  • MS Quality of Life (MSQoli 54) [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    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.
  • MS Quality of life inventory (MSQLI) [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.
  • Demographic data [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    Questions about demographic attributes such as race, education, handedness.
  • Functional Medicine assessment summary [ Time Frame: Baseline or 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Veteran Specific Activity Quest. [ Time Frame: Baseline and 12 weeks. ] [ Designated as safety issue: No ]
    Series of questions about the tasks of daily life to identify how much activity the individual can safely do.
  • MS Function Scale [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
    A series of questions about the tasks of daily life.
  • Satiety scale [ Time Frame: Baseline and weeks 10 and 11 ] [ Designated as safety issue: No ]
    A series of questions about the sense of satiety or sense of fullness.
  • Harvard Food Frequency Quest. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    Brachial artery FMD and endothelium-independent dilation will be determined non-invasively using high-resolution ultrasonography.
  • Expanded disability status score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Assessment of disability status
  • Biomarkers [ Time Frame: Time 0 through 12 weeks ] [ Designated as safety issue: Yes ]
    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. CRP
  • Biomarkers - glucose and ketones [ Time Frame: time 0 through 4, 8, 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Nutrient intake [ Time Frame: Time 0 and 12 weeks ] [ Designated as safety issue: No ]
    This will include Harvard Food Frequency Questionnaires at baseline and study conclusion and the nutrient analyses as a result. The 24 hr recalls will be collected at baseline in in the last4 weeks of study. This will include nutrient analyses as well. Satiety scales will also be completed.
  • Daily Food logs [ Time Frame: Time zero through end of study (12 weeks) ] [ Designated as safety issue: No ]
    This is a record of daily food and beverage consumption. The full intervention group will keep the record daily. The minimal intervention will keep the full record the initial two weeks and for three additional one week blocks during the study.
  • MS functional composite [ Time Frame: Time zero through end of study (12 weeks) ] [ Designated as safety issue: No ]
    This a composite of tests involving tests of walking, hand coordination and mental addition.
Not Provided
Demographic and medical comorbidities [ Time Frame: Time zero ] [ Designated as safety issue: No ]
Medical examination, neurologic examination, past medical history, medication, vitamin and supplement usage.
 
Wahls Paleo Diet and Progressive Multiple Sclerosis
Wahls Paleo Diet and Progressive Multiple Sclerosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
  • 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 Name: Wahls Paleo Plus (ketogenic diet)
  • 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.
    Other Name: Wahls Diet (modified paleolithic diet)
  • Experimental: Wahls Paleo Plus
    Wahls Paleo Plus diet (ketogenic diet)
    Intervention: Other: Wahls Paleo Plus
  • Experimental: Wahls Diet
    Wahls Diet (modified paleolithic diet)
    Intervention: Other: Wahls Diet
  • No Intervention: Usual Care
    Control - usual care only.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
September 2014
September 2014   (final data collection date for primary outcome measure)

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.

Both
30 Years to 65 Years
No
Contact: Alexander Wallace, BA 319 338 0581 ext 6080 Alexander.Wallace@va.gov
Contact: Babita Bisht, MA 319 338 0581 ext 6080 Babita-bisht@uiowa.edu
United States
 
NCT01915433
201302829
No
University of Iowa
University of Iowa
Not Provided
Not Provided
University of Iowa
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP