Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS

NCT03718247 | Completed

• 1 other identifier: 20877
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Ketogenic diet

Outcome Measures

Primary Outcomes (2)

• Diet Tolerability and compliance

  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.

  6 months

• Diet Benefits

  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.

  12 months

Secondary Outcomes (1)

• Physical changes

  12 months

Interventions

Modified Atkins diet OTHER

High fat low carbohydrate diet.

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing-remitting MS

You may qualify if:

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

You may not qualify if:

• Comorbid disease (including hypercholesterolemia, cardiovascular or renal disease) that would interfere with safety and/or study completion
• Current pregnancy or planning pregnancy
• Progressive form of MS
• Estimated GFR less than 45 mL/min based on a serum creatinine drawn within 30 days of enrollment
• Acute kidney injury
• History of paraproteinemia syndromes such as multiple myeloma
• Hepatorenal syndrome
• Liver transplant
• Underweight or low weight patients as defined by:
• BMI value \<20 for those 18 years and older
• \<10th percentile for BMI by CDC growth charts for those less than 18 years of age

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (7)

• Zhao Z, Lange DJ, Voustianiouk A, MacGrogan D, Ho L, Suh J, Humala N, Thiyagarajan M, Wang J, Pasinetti GM. A ketogenic diet as a potential novel therapeutic intervention in amyotrophic lateral sclerosis. BMC Neurosci. 2006 Apr 3;7:29. doi: 10.1186/1471-2202-7-29.

  PMID: 16584562 BACKGROUND

• Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.

  PMID: 23007702 BACKGROUND

• van Horssen J, Schreibelt G, Drexhage J, Hazes T, Dijkstra CD, van der Valk P, de Vries HE. Severe oxidative damage in multiple sclerosis lesions coincides with enhanced antioxidant enzyme expression. Free Radic Biol Med. 2008 Dec 15;45(12):1729-37. doi: 10.1016/j.freeradbiomed.2008.09.023. Epub 2008 Oct 7.

  PMID: 18930811 BACKGROUND

• Perlman J, Wetmore E, Lehner-Gulotta D, Banwell B, Bergqvist AGC, Coleman R, Chen S, Conaway M, Goldman MD, Morse AM, Brenton JN. Impact of a ketogenic diet on sleep quality in people with relapsing multiple sclerosis. Sleep Med. 2024 Oct;122:213-220. doi: 10.1016/j.sleep.2024.08.020. Epub 2024 Aug 28.

  PMID: 39208520 DERIVED

• Wetmore E, Lehner-Gulotta D, Florenzo B, Banwell B, Bergqvist AGC, Coleman R, Conaway M, Goldman MD, Brenton JN. Ketogenic diet in relapsing multiple sclerosis: Patient perceptions, post-trial diet adherence & outcomes. Clin Nutr. 2023 Aug;42(8):1427-1435. doi: 10.1016/j.clnu.2023.06.029. Epub 2023 Jul 4.

  PMID: 37433230 DERIVED

• Oh U, Woolbright E, Lehner-Gulotta D, Coleman R, Conaway M, Goldman MD, Brenton JN. Serum neurofilament light chain in relapsing multiple sclerosis patients on a ketogenic diet. Mult Scler Relat Disord. 2023 May;73:104670. doi: 10.1016/j.msard.2023.104670. Epub 2023 Mar 25.

  PMID: 36996634 DERIVED

• Brenton JN, Lehner-Gulotta D, Woolbright E, Banwell B, Bergqvist AGC, Chen S, Coleman R, Conaway M, Goldman MD. Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits. J Neurol Neurosurg Psychiatry. 2022 Jun;93(6):637-644. doi: 10.1136/jnnp-2022-329074. Epub 2022 Apr 13.

  PMID: 35418509 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rectal swab

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Pediatrics

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 24, 2018
• Study Start: October 31, 2018
• Primary Completion: June 21, 2021
• Study Completion: July 1, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

US (1)