Clinical trial NCT01538355: A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: multiple sclerosis
diet
prolonged fasting
caloric restriction
ketogenic low glycemic load treatment
health related quality of life
ketogenic diet
neurodegeneration
neuroinflammation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this controlled randomised pilot study the patients are allocated to 1. a ketogenic low glycemic load treatment from the outset of the study for 24 weeks or 2. enhance their regular diet with an initial 7-day fasting followed by a Mediterranean diet pattern until the study end or 3. stay on their regular diet (control group) from the outset of the study for 24 weeks. The investigators will then assess the differences between the groups.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.
timeFrame: Visit: Baseline, month 1, month 3 and month 6
Secondary outcomes:
measure: Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.
timeFrame: Visits: Baseline, month 1, month 3 and month 6
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin
Study officials:
affiliation: Charité-Universitätsmedizin Berlin, Berlin Germany
name: Markus Bock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Bock M, Steffen F, Zipp F, Bittner S. Impact of Dietary Intervention on Serum Neurofilament Light Chain in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 11;9(1):e1102. doi: 10.1212/NXI.0000000000001102. Print 2022 Jan.
citation: Bock M, Karber M, Kuhn H. Ketogenic diets attenuate cyclooxygenase and lipoxygenase gene expression in multiple sclerosis. EBioMedicine. 2018 Oct;36:293-303. doi: 10.1016/j.ebiom.2018.08.057. Epub 2018 Oct 3.
citation: 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.