A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogen
A Randomised Controlled Pilot Study to Compare the Effects of Prolonged Fasting and Ketogenic Low Glycemic Load Treatment on Health Related Quality of Life in Relapsing-remitting Multiple Sclerosis.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Prolonged Fasting
- Ketogenic low glycemic load treatment
- Control diet
What it measured
Main measures
Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
Visit: Baseline, month 1, month 3 and month 6
Quality of life (reported by participants)Feasibility
Other measures (1)
Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.
Visits: Baseline, month 1, month 3 and month 6
FatiguePhysical functionQuality of life (reported by participants)Safety
Who could take part
Relapsing MS · 18 to 68
Show the full criteria
Inclusion criteria
* Relapsing remitting MS * Stable immunomodulatory treatment or no treatment at least 6 months prior to inclusion * Expanded disability status scale \< 7 * Body mass index (BMI) > or = 18,5 OR BMI > or = 45 with no risk factors * Not pregnant or breast-feeding * No serious mental health illness such as dementia or schizophrenia; * No use of a weight loss therapy in the month prior to screening.
Exclusion criteria
* Start or changes if immunomodulatory treatment \< 7 months prior to screening * SPMS or PPMS * Relapse or corticosteroid use \< 30 days prior to screening * Diabetes or any metabolic defects * Bulimia * Anorexia * Drug abuse
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
It is well accepted that nutrition as an environmental factor is involved in the pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes there is. Primarily the investigators want to detect if these diets are feasible for MS patients. Therefore the investigators examine the impact of this dietary intervention on the health related quality of life for individuals after 7 days, 3 months and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological and immunological changes after 7 days, 3 months and 6 months in compare to baseline.
Papers
Results
Impact of Dietary Intervention on Serum Neurofilament Light Chain in Multiple Sclerosis.Neurol Neuroimmunol Neuroinflamm · 2022
Results
Ketogenic diets attenuate cyclooxygenase and lipoxygenase gene expression in multiple sclerosis.EBioMedicine · 2018
Results
A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms.Cell Rep · 2016
Results
Swidsinski A, Dorffel Y, Loening-Baucke V, Gille C, Goktas O, Reisshauer A, Neuhaus J, Weylandt KH, Guschin A, Bock M. Reduced Mass and Diversity of the Colonic Microbiome in Patients with Multiple Sclerosis and Their Improvement with Ketogenic Diet. Front Microbiol. 2017 Jun 28;8:1141. doi: 10.3389/fmicb.2017.01141. eCollection 2017.Background
Piccio L, Stark JL, Cross AH. Chronic calorie restriction attenuates experimental autoimmune encephalomyelitis. J Leukoc Biol. 2008 Oct;84(4):940-8. doi: 10.1189/jlb.0208133. Epub 2008 Aug 4.Background
Kim DY, Hao J, Liu R, Turner G, Shi FD, Rho JM. Inflammation-mediated memory dysfunction and effects of a ketogenic diet in a murine model of multiple sclerosis. PLoS One. 2012;7(5):e35476. doi: 10.1371/journal.pone.0035476. Epub 2012 May 2.
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History
Started
Jul 2012
Main results due
Feb 2013
Finished
Jun 2020