Relapsing-Remitting Multiple SclerosisIGELNCT01538355
A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis
A study testing Prolonged Fasting and Ketogenic low glycemic load treatment in people with Relapsing-Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Prolonged Fasting and Ketogenic low glycemic load treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jul 2012to 23 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Prolonged Fasting, Ketogenic low glycemic load treatment, Control diet
- Keywords
- multiple sclerosis, diet, prolonged fasting, caloric restriction, ketogenic low glycemic load treatment, health related quality of life, ketogenic diet, neurodegeneration, neuroinflammation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Nerve Degeneration, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged FastingOther
Patients enhance their regular diet with an initial 7-day fasting episode.
Ketogenic low glycemic load treatmentOther
6 months of ketogenic low glycemic load treatment from the study outset.
Control dietOther
Patients stay on their regular diet.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged fasting | Experimental | Patients undergo an initial 7-day fasting episode. Receives: Other: Prolonged Fasting |
| Ketogenic low glycemic load treatment | Experimental | Patients receive a ketogenic low glycemic load treatment from the outset of the study. Receives: Other: Ketogenic low glycemic load treatment |
| Control diet | Experimental | Patients stay on their regular diet. Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Multiple sclerosis functional composite; fatigue scores, body composition; body weight; lipid profile, liver enzymes, insulin, glucagon
Measured: Visits: Baseline, month 1, month 3 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study start30 Jul 2012
- Primary completion28 Feb 2013
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Bock, MD, Charite University, Berlin, Germany
- Investigators
- Markus Bock, MD, Principal investigator, Charité-Universitätsmedizin Berlin, Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538355
- Sponsor's protocol ID
- IGEL
- Acronym
- IGEL
- Status last verified
- Apr 2021
- First submitted
- 15 Feb 2012
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18678605Kim 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.
PubMed 22567104Swidsinski 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.
PubMed 28702003Bock 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.
PubMed 34764215Bock 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.
PubMed 30292675Choi 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.
PubMed 27239035
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01538355
- Acronym / sponsor ID
- IGEL / IGEL
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 30 Jul 2012 (actual)
- Primary completion
- 28 Feb 2013 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged fasting | Experimental | Other: Prolonged FastingPatients undergo an initial 7-day fasting episode. |
| Ketogenic low glycemic load treatment | Experimental | Other: Ketogenic low glycemic load treatmentPatients receive a ketogenic low glycemic load treatment from the outset of the study. |
| Control diet | Experimental | Other: Control dietPatients stay on their regular diet. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged FastingPatients enhance their regular diet with an initial 7-day fasting episode. | Other | Prolonged fasting |
| Ketogenic low glycemic load treatment6 months of ketogenic low glycemic load treatment from the study outset. | Other | Ketogenic low glycemic load treatment |
| Control dietPatients stay on their regular diet. | Other | Control diet |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 18678605Piccio 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.
- Background: PubMed 22567104Kim 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 publication: PubMed 28702003Swidsinski 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.
- Derived from this study: PubMed 34764215Bock 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.
- Derived from this study: PubMed 30292675Bock 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.
- Derived from this study: PubMed 27239035Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Bock, MD principal investigator
Charité-Universitätsmedizin Berlin, Berlin Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Fasting and Ketogenic low glycemic load treatment in people with Relapsing-Remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538355, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.