A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis

NCT01538355 | Completed

• 1 other identifier: IGEL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months.

  Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.

  Visit: Baseline, month 1, month 3 and month 6

Secondary Outcomes (1)

• Adherence rates, number of participants with adverse events and laboratory parameters at 6 months.

  Visits: Baseline, month 1, month 3 and month 6

Study Arms (3)

Prolonged fasting

EXPERIMENTAL

Patients undergo an initial 7-day fasting episode.

Other: Prolonged Fasting

Ketogenic low glycemic load treatment

EXPERIMENTAL

Patients receive a ketogenic low glycemic load treatment from the outset of the study.

Other: Ketogenic low glycemic load treatment

Control diet

EXPERIMENTAL

Patients stay on their regular diet.

Other: Control diet

Interventions

Prolonged Fasting OTHER

Patients enhance their regular diet with an initial 7-day fasting episode.

Prolonged fasting

Ketogenic low glycemic load treatment OTHER

6 months of ketogenic low glycemic load treatment from the study outset.

Ketogenic low glycemic load treatment

Control diet OTHER

Patients stay on their regular diet.

Control diet

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsing remitting MS
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

Related Publications (6)

• 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.

  PMID: 18678605 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.

  PMID: 22567104 BACKGROUND

• 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.

  PMID: 28702003 RESULT

• 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.

  PMID: 34764215 DERIVED

• 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.

  PMID: 30292675 DERIVED

• 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.

  PMID: 27239035 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Nerve Degeneration; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Study Officials

• Markus Bock, MD

  Charité-Universitätsmedizin Berlin, Berlin Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 24, 2012
• Study Start: July 30, 2012
• Primary Completion: February 28, 2013
• Study Completion: June 23, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

DE (1)