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Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS

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ClinicalTrials.gov Identifier: NCT03718247
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
J. Nicholas Brenton, MD, University of Virginia

Brief Summary:
The purpose of this study is to evaluate the benefits of a low-carbohydrate, high-fat diet (ketogenic diet) in up to 50 subjects with relapsing-remitting multiple sclerosis (RRMS), a chronic neuro-inflammatory disease. The primary aim of this study is to provide evidence of tolerability of the ketogenic diet in patients with RRMS. The principal investigator hypothesizes that the diet may prove beneficial for participants disease state in multiple potential ways.The study consists of 5 visits over a 12 month period. During these visits subjects will undergo fasting lab work, micro-biome sampling, neurological testing, body composition analysis, meeting with dietitian, and will be asked to complete surveys as well as a diet recall log.

Condition or disease Intervention/treatment
Relapsing Remitting Multiple Sclerosis Other: Modified Atkins diet

Detailed Description:

The purpose of this study is to see if a high fat, low carbohydrate diet is safe and how it effects post trial diet habits, physique, and disease course in patients with relapsing remitting multiple sclerosis. In particular, multiple sclerosis is a neurodegenerative disorder that is characterized by inflammation, microglial inflammation, and hypoxia in its relapsing-remitting form.1 One of the hypothesized therapeutic mechanisms of ketogenic diets is related to its effect on decreasing glycolysis, decreasing reactive oxygen species (ROS), and increasing ATP production by mitochondria. Production of ROS and macrophage activation have been directly correlated with demyelination and axonal injury in multiple sclerosis.2,3 In mouse models with experimental allergic encephalomyelitis (EAE), a model disease in mice that has many similar properties to that of MS in humans, experiments have demonstrated that impairment of memory and spatial learning are directly correlated with increased cytokine and chemokine expression and ROS production. In EAE mice fed a ketogenic diet, there were noted improvements in motor disability, memory dysfunction, and CNS inflammation - which on the whole are suggestive that a ketogenic diet may have a multitude of benefits in patients with multiple sclerosis.

The study goal is to recruit 50 young adult or adult patients with relapsing-remitting multiple sclerosis that show interest in starting and maintaining a ketogenic diet for six months. Prior to initiating the diet, the study team will characterize each patient's disease by analyzing multiple factors - including baseline expanded disability status scale (EDSS) and annualized relapse rates (ARR). Throughout the course of the 12 month study participants will be asked to complete several patient reported outcomes, an online food diary recall, and track their diet compliance using urinary ketone testing strips provided by the study daily.In addition, the study team will also draw serum lab work every 3 months that we anticipate may be affected by the diet (including hemoglobin A1C, lipid panel, and cytokine profiles). Rectal swabs will be requested during the study to look at effects of the diet on the microbiome both pre and post diet. Additionally, activity monitors (accelerometers) will be worn by each subject for 1 week prior to initiation of the diet to provide evidence of pre-diet activity levels and at various times throughout the study for comparison. Participating patients will receive education on starting, maintaining, and stopping the 6 month diet by a nutritionist. The nutritionist will meet with patients at scheduled office visits and will be available for questions during the duration of the patients participation. Subjects will also undergo anthropometric assessments with a bodpod used to measure body mass as well.

All measures will be compared with statistical analyses, utilizing both pre and post diet values to help determine benefit of the diet on various aspects of the patient's overall health and wellness.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of the Ketogenic Diet on Patients With Relapsing Remitting Multiple Sclerosis
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Modified Atkins diet
    High fat low carbohydrate diet.


Primary Outcome Measures :
  1. Diet Tolerability and compliance [ Time Frame: 6 months ]
    Determine if patients are able to adhere to (number of days patient able to demonstrate ketosis) and tolerate a strict diet over an extended period of time as reported in urinary ketone analysis.

  2. Diet Benefits [ Time Frame: 12 months ]
    Determine the benefits, if any, of the ketogenic diet in RRMS subjects physically, emotionally, and clinically as reported in patient reported outcome surveys. Survey responses are evaluated on a scale of 0-10 with 0 being no affect and 10 being highly affected by the disease.


Secondary Outcome Measures :
  1. Physical changes [ Time Frame: 12 months ]
    Assessment of height and weight to calculate subject BMI throughout the study. This will be compared with survey on physical activity to see if scores (no disease impact to high disease impact on activity) correspond with changes in BMI.


Biospecimen Retention:   Samples Without DNA
Rectal swab


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsing-remitting MS
Criteria

Inclusion Criteria:

  1. Ability to provide informed consent (or assent for minors)
  2. Relapsing-remitting MS diagnosis per 2010 McDonald criteria
  3. On same Demyelinating Treatment for at least 6 months
  4. Ages ≥ 12 years to ≤ 45 years

Exclusion Criteria:

  1. Comorbid disease (including hypercholesterolemia, cardiovascular or renal disease) that would interfere with safety and/or study completion
  2. Current pregnancy or planning pregnancy
  3. Progressive form of MS
  4. Estimated GFR less than 45 mL/min based on a serum creatinine drawn within 30 days of enrollment
  5. Acute kidney injury
  6. History of paraproteinemia syndromes such as multiple myeloma
  7. Hepatorenal syndrome
  8. Liver transplant
  9. Underweight or low weight patients as defined by:

    1. BMI value <20 for those 18 years and older
    2. <10th percentile for BMI by CDC growth charts for those less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718247


Contacts
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Contact: James N Brenton, MD 434924-3035 jnb8h@virginia.edu
Contact: Rachael Coleman, MPH 434-297-4102 rcoleman@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Rachael Coleman, MPH    434-297-4102    rcoleman@virginia.edu   
Principal Investigator: J Nicholas Brenton, MD         
Sponsors and Collaborators
University of Virginia

Publications:
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Responsible Party: J. Nicholas Brenton, MD, Assistant Professor of Neurology and Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT03718247     History of Changes
Other Study ID Numbers: 20877
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J. Nicholas Brenton, MD, University of Virginia:
Ketogenic diet

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases