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

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ClinicalTrials.gov Identifier: NCT01538355
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Markus Bock, MD, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Other: Prolonged Fasting Other: Ketogenic low glycemic load treatment Other: Control diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 30, 2012
Actual Primary Completion Date : February 28, 2013
Actual Study Completion Date : June 23, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prolonged fasting
Patients undergo an initial 7-day fasting episode.
 Other: Prolonged Fasting
Patients enhance their regular diet with an initial 7-day fasting episode.
Experimental: Ketogenic low glycemic load treatment
Patients receive a ketogenic low glycemic load treatment from the outset of the study.
 Other: Ketogenic low glycemic load treatment
6 months of ketogenic low glycemic load treatment from the study outset.
Experimental: Control diet
Patients stay on their regular diet.
 Other: Control diet
Patients stay on their regular diet.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Multiple Sclerosis Quality of Life-54 questionnaire: Proof of feasibility at 6 months. [ Time Frame: Visit: Baseline, month 1, month 3 and month 6 ]
    Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.


Secondary Outcome Measures :
  1. Adherence rates, number of participants with adverse events and laboratory parameters at 6 months. [ Time Frame: Visits: Baseline, month 1, month 3 and month 6 ]
    Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538355


Locations
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Germany
Charité-Universitätsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Markus Bock, MD Charité-Universitätsmedizin Berlin, Berlin Germany
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Markus Bock, MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01538355    
Other Study ID Numbers: IGEL
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Keywords provided by Markus Bock, MD, Charite University, Berlin, Germany:
multiple sclerosis
diet
prolonged fasting
caloric restriction
ketogenic low glycemic load treatment
 health related quality of life
ketogenic diet
neurodegeneration
neuroinflammation
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases