Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
The Effects of Ketogenic Diet Therapy Versus the Mediterranean Diet on Quality of Life in a Group of Patients With Multiple Sclerosis - the KETOMED-MS Study
What it found
No result yet.
What was tested
Treatment tested
- Mediterranean Diet
- Ketogenic Diet
- Control group
What it measured
Main measures
The CPH subscale of the Multiple Sclerosis Quality of Life-54 (MSQoL -54)
Evaluation at baseline and after 6 months
Quality of life (reported by participants)
Other measures (5)
Expanded Disability Status Scale (EDSS)
Evaluation at baseline and after 6 months
Disability progressionVisionBladder, bowel and sexual functionMultiple Sclerosis Functional Composite (MSFC)
Evaluation at baseline and after 6 months
Disability progressionThinking and memoryWalking and mobilityArm and hand functionModified Fatigue Impact Scale (MFIS)
Evaluation at baseline and after 6 months
Thinking and memoryFatigueThe Pittsburgh Sleep Quality Index
Evaluation at baseline and after 6 months
Myelin repairMood and sleepThe Beck Depression Inventory
Evaluation at baseline and after 6 months
Thinking and memoryFatigueMood and sleep
Who could take part
Relapsing and progressive · 18 to 60
Show the full criteria
Inclusion criteria
* Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS) * Age between 18 and 60 years * BMI between 18.5 kg/m2 and 39.9 kg/m2 * If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months * Ability to give verbal and written consent
Exclusion criteria
* Patients actively engaged in a weight loss program or other specific diet (e.g. vegetarian, vegan); patients not willing to follow the assigned dietary pattern or patients with high adherence to MedDiet (MediLite score > 14) * Pregnancy or breastfeeding * Relapse or cortisone treatment within 30 days before study entry * Clinically relevant metabolic, progressive or malignant diseases * Intake of > 1 g/day of omega-3 fatty acid supplements * Underweight (BMI\<18.5 kg/m2) or severe obesity * Significant cognitive-cooperative impairment * Insulin-dependent diabetes mellitus (type I) * Weight loss greater than 5 kg within 2 months prior to study entry * Diagnosis or suspicion of an eating disorder * Kidney stones * Oral anticoagulant therapy * Known alcohol and drug abuse Telephonic interviews will be performed monthly to evaluate adherence to the dietary treatment and/or whether any changes in supplements use, physical activity, nutrition habits.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Multiple sclerosis (MS) is an inflammatory and immune-mediated neurological disease with multifactorial etiology. The specific etiopathogenetic mechanisms of MS are still unknown but it is clear that it results from a combination of genetic and environmental factors. Several studies have reported the possible role of diet as a risk factor for MS and its progression. To date, many dietary patterns and their association with MS have been studied, but data is still limited and inconclusive. Mediterranean Diet (MedDiet) has been associated with a lower risk of developing MS, compared to a Western-style diet. In one of investigators' studies, higher MedDiet adherence was associated with a 6-fold greater likelihood of having lower disease severity than those with low adherence. A significant restriction of carbohydrates (up to ketogenesis) can have beneficial effects on various parameters (inflammatory markers, oxidative stress, altered glucose metabolism) which are altered in subjects with MS. Ketogenic diet therapies (KDTs) have been recommended mainly for children with drug-resistant epilepsy, but in recent years they have been applied to Multiple Sclerosis. Preclinical studies in animal models evaluating the efficacy of KDTs in experimental autoimmune encephalomyelitis (EAE) found a beneficial effect of diet in slowing of disease progression, improvement of motor disability, reduction of inflammatory cytokines and reactive oxygen species. In a randomized study, improvements in health-related quality of life (HRQL) scores and a slight decrease in EDSS scores were found. An open-label, single-arm study of 20 patients with RRMS also reported that, after 6 months of MAD, no subjects had new or enlarging FLAIR/T2 lesions, with a significant improvement in the EDSS score, the Modified Fatigue Impact Scale subscales and arm. A 3-arm parallel-arm randomized controlled pilot study was planned to determine the effectiveness of a modified Atkins diet (MAD) compared to a Mediterranean diet (MedDiet) on quality of life in a population with MS.
Papers
Results
Guglielmetti M, Al-Qahtani WH, Ferraris C, Grosso G, Fiorini S, Tavazzi E, Greco G, La Malfa A, Bergamaschi R, Tagliabue A. Adherence to Mediterranean Diet Is Associated with Multiple Sclerosis Severity. Nutrients. 2023 Sep 16;15(18):4009. doi: 10.3390/nu15184009.Background
Alfredsson L, Olsson T, Hedstrom AK. Inverse association between Mediterranean diet and risk of multiple sclerosis. Mult Scler. 2023 Aug;29(9):1118-1125. doi: 10.1177/13524585231181841. Epub 2023 Jun 27.Background
Ascherio A. Environmental factors in multiple sclerosis. Expert Rev Neurother. 2013 Dec;13(12 Suppl):3-9. doi: 10.1586/14737175.2013.865866.Background
Ayromlou H, Hosseini S, Khalili M, Ayromlou S, Khamudchiyan S, Farajdokht F, Hassannezhad S, Amiri Moghadam S. Insulin resistance is associated with cognitive dysfunction in multiple sclerosis patients: A cross-sectional study. J Neuroendocrinol. 2023 Jun;35(6):e13288. doi: 10.1111/jne.13288. Epub 2023 Jun 15.Background
Azary S, Schreiner T, Graves J, Waldman A, Belman A, Guttman BW, Aaen G, Tillema JM, Mar S, Hart J, Ness J, Harris Y, Krupp L, Gorman M, Benson L, Rodriguez M, Chitnis T, Rose J, Barcellos LF, Lotze T, Carmichael SL, Roalstad S, Casper CT, Waubant E. Contribution of dietary intake to relapse rate in early paediatric multiple sclerosis. J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):28-33. doi: 10.1Background
Black LJ, Rowley C, Sherriff J, Pereira G, Ponsonby AL, Lucas RM. A healthy dietary pattern associates with a lower risk of a first clinical diagnosis of central nervous system demyelination. Mult Scler. 2019 Oct;25(11):1514-1525. doi: 10.1177/1352458518793524. Epub 2018 Aug 7.Background
Brenton JN, Banwell B, Bergqvist AGC, Lehner-Gulotta D, Gampper L, Leytham E, Coleman R, Goldman MD. Pilot study of a ketogenic diet in relapsing-remitting MS. Neurol Neuroimmunol Neuroinflamm. 2019 Apr 12;6(4):e565. doi: 10.1212/NXI.0000000000000565. eCollection 2019 Jul.Background
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.Background
Choi IY, Piccio L, Childress P, Bollman B, Ghosh A, Brandhorst S, Suarez J, Michalsen A, Cross AH, Morgan TE, Wei M, Paul F, Bock M, Longo VD. A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms. Cell Rep. 2016 Jun 7;15(10):2136-2146. doi: 10.1016/j.celrep.2016.05.009. Epub 2016 May 26.Background
Esposito S, Bonavita S, Sparaco M, Gallo A, Tedeschi G. The role of diet in multiple sclerosis: A review. Nutr Neurosci. 2018 Jul;21(6):377-390. doi: 10.1080/1028415X.2017.1303016. Epub 2017 Mar 24.
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History
Started
Mar 2024
Main results due
Mar 2025
Finished
Sept 2025