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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Prolonged Fasting

Ketogenic low glycemic load treatment

Control diet

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring multiple sclerosis, diet, prolonged fasting, caloric restriction, ketogenic low glycemic load treatment, health related quality of life, ketogenic diet, neurodegeneration, neuroinflammation

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charité-Universitätsmedizin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Prolonged fasting

Ketogenic low glycemic load treatment

Control diet

Arm Description

Patients undergo an initial 7-day fasting episode.

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

Patients stay on their regular diet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon

Full Information

NCT ID

NCT01538355

First Posted

February 15, 2012

Last Updated

April 6, 2021

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT01538355

Brief Title

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

Acronym

IGEL

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 30, 2012 (Actual)

Primary Completion Date

February 28, 2013 (Actual)

Study Completion Date

June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prolonged fasting

Arm Type

Experimental

Arm Description

Patients undergo an initial 7-day fasting episode.

Arm Title

Ketogenic low glycemic load treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Control diet

Arm Type

Experimental

Arm Description

Patients stay on their regular diet.

Intervention Type

Other

Intervention Name(s)

Prolonged Fasting

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Ketogenic low glycemic load treatment

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control diet

Intervention Description

Patients stay on their regular diet.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Bock, MD

Organizational Affiliation

Charité-Universitätsmedizin Berlin, Berlin Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité-Universitätsmedizin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

18678605

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.

Results Reference

background

PubMed Identifier

22567104

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.

Results Reference

background

PubMed Identifier

28702003

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.

Results Reference

result

PubMed Identifier

34764215

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.

Results Reference

derived

PubMed Identifier

30292675

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.

Results Reference

derived

PubMed Identifier

27239035

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.

Results Reference

derived

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

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