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

April 6, 2021 updated by: Markus Bock, MD, Charite University, Berlin, Germany

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité-Universitätsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit: Baseline, month 1, month 3 and month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visits: Baseline, month 1, month 3 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Markus Bock, MD, Charité-Universitätsmedizin Berlin, Berlin Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2012

Primary Completion (Actual)

February 28, 2013

Study Completion (Actual)

June 23, 2020

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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