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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Bock, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01538355
First received: February 15, 2012
Last updated: February 15, 2015
Last verified: February 2015
  Purpose

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 Intervention
Relapsing-Remitting Multiple Sclerosis
Other: Prolonged Fasting
Other: Ketogenic low glycemic load treatment
Other: Control diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Two summary scores: physical health und mental health, 12 subscales and 2 single item scales.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon


Enrollment: 48
Study Start Date: December 2011
Study Completion Date: January 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538355

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

Publications:
Responsible Party: Markus Bock, MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01538355     History of Changes
Other Study ID Numbers: IGEL
Study First Received: February 15, 2012
Last Updated: February 15, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by 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:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 03, 2015