NCT03718247

Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS

Completed Last updated 18 May 2022

What this trial tests

trial testing Modified Atkins diet in Relapsing Remitting Multiple Sclerosis in 45 participants. Completed in 1 July 2021.

Timeline

31 October 2018

Primary endpoint
21 June 2021

1 July 2021

Quick facts

Lead sponsor	University of Virginia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	45
Start date	31 October 2018
Primary completion	21 June 2021
Estimated completion	1 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Modified Atkins diet

Conditions studied

• Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →

Sponsor

University of Virginia

Who can join

Adults 12 to 55, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits.
   Brenton JN, Lehner-Gulotta D, Woolbright E, Banwell B, et al · · 2022 · cited 69× · PMID 35418509 · DOI 10.1136/jnnp-2022-329074
2. Alzheimer's disease alters oligodendrocytic glycolytic and ketolytic gene expression.
   Saito ER, Miller JB, Harari O, Cruchaga C, et al · · 2021 · cited 49× · PMID 33650792 · DOI 10.1002/alz.12310
3. Current Insights Into Oligodendrocyte Metabolism and Its Power to Sculpt the Myelin Landscape.
   Narine M, Colognato H. · · 2022 · cited 43× · PMID 35573837 · DOI 10.3389/fncel.2022.892968
4. Dietary protection against the visual and motor deficits induced by experimental autoimmune encephalomyelitis.
   Zyla-Jackson K, Walton DA, Plafker KS, Kovats S, et al · · 2023 · cited 17× · PMID 36937529 · DOI 10.3389/fneur.2023.1113954
5. Serum neurofilament light chain in relapsing multiple sclerosis patients on a ketogenic diet.
   Oh U, Woolbright E, Lehner-Gulotta D, Coleman R, et al · · 2023 · cited 13× · PMID 36996634 · DOI 10.1016/j.msard.2023.104670
6. Ketogenic diet in relapsing multiple sclerosis: Patient perceptions, post-trial diet adherence & outcomes.
   Wetmore E, Lehner-Gulotta D, Florenzo B, Banwell B, et al · · 2023 · cited 12× · PMID 37433230 · DOI 10.1016/j.clnu.2023.06.029
7. Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern.
   Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. · · 2019 · cited 8× · PMID 30871265 · DOI 10.3390/nu11030616
8. Immunosenescence in aging and neurodegenerative diseases: evidence, key hallmarks, and therapeutic implications.
   Chen Z, Mao Z, Tang W, Shi Y, et al · · 2025 · cited 4× · PMID 41299782 · DOI 10.1186/s40035-025-00517-1