Multiple SclerosisNCT03508414
Nutritional Approaches in Multiple Sclerosis
A study testing ketogenic diet, Intermittent therapeutical fasting and Active comparator in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ketogenic diet, Intermittent therapeutical fasting and Active comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2017to 1 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Existing health insurance, so that in case of random findings these can also be clarified
- Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010
- Age 18-65
- Consent ability and written consent
- BMI between 19 and 45 kg / m2
- EDSS <4.5
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- Stable immunomodulatory therapy or no immunomodulatory therapy> 6 months before confinement
- In the last 2 years ≥ 1 relapse or within the last 2 years ≥ 1 new T2 lesions or ≥ 1 contrast-sensitive lesion in MRT
- Consent that possible random findings are reported
Who cannot join
- Initiation or modification of immunomodulatory therapy during the study
- Cortisone treatment in the last 30 days before enrollment
- Relapse in the last 30 days before enrollment
- Insulin-dependent diabetes mellitus (type I)
- Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day
- Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
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- Malignant disease
- Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
- Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
- Nicotine consumption of > 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting.
- Insufficient mental possibility of cooperation
- Eating disorder
- Kidney stones
- Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis / ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., nesidioblastoma), pyruvate carboxylase deficiency)
- Therapy with oral anticoagulants (e.g., Marcumar)
- Pregnancy and breast feeding period
- Suspected lack of compliance
- Performing of a diet for weight reduction
- Special diet for medical reasons
- Change of the body weight of more than 5 kg within one month before the start of the Intervention
- Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
- Contraindications to MRT examinations [persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia]
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.
- Conditions
- Multiple Sclerosis
- Being tested
- ketogenic diet, Intermittent therapeutical fasting, Active comparator
- Keywords
- Relapse-remitting Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketogenic dietBehavioural
Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.
Intermittent therapeutical fastingBehavioural
Patients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day.
Active comparatorBehavioural
The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Not described Receives: Behavioral: ketogenic diet |
| Intermittent therapeutical fasting | Experimental | Not described Receives: Behavioral: Intermittent therapeutical fasting |
| Control group | Active comparator | The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. Receives: Behavioral: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral T2 lesions from Baseline at 18 months
Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT
Measured: Change from baseline at 18 months
Secondary outcomes (4)
Change in neurological-functional disability: physical and cognitive function
influence of the interventions on cognitive and physical disability progression using Multiple Sclerosis Functional Composite (MSFC)
Measured: Change from baseline at 9 and 18 months
Change in neurological-functional disability : physical function
influence of the interventions on physical disability progression using Expanded Disability Status Score (EDSS). The EDSS is assessing the progress of disability in MS patients with a scale between 0-12 points, while 0 indicates no disability and 10 indicates death through MS.
Measured: Change from baseline at 9 and 18 months
annual relapse rate
relapse rate
Measured: 12 months
progress of brain atrophy
PBVC = percent brain volume change
Measured: Change from baseline at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start11 Apr 2017
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508414
- Sponsor's protocol ID
- NAMS-study
- Status last verified
- Jul 2021
- First submitted
- 21 Dec 2017
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahr LS, Bellmann-Strobl J, Koppold DA, Rust R, Schmitz-Hubsch T, Olszewska M, Stadlbauer J, Bock M, Scheel M, Chien C, Multmeier J, Krannich A, Michalsen A, Paul F, Mahler A. Fasting, ketogenic, and anti-inflammatory diets in multiple sclerosis: a randomized controlled trial with 18-month follow-up. BMC Nutr. 2025 Aug 20;11(1):167. doi: 10.1186/s40795-025-01156-5.
PubMed 40836308Bahr LS, Bock M, Liebscher D, Bellmann-Strobl J, Franz L, Pruss A, Schumann D, Piper SK, Kessler CS, Steckhan N, Michalsen A, Paul F, Mahler A. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9.
PubMed 31898518
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Approaches in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03508414
- Acronym / sponsor ID
- NAMS-study
- Conditions
- Multiple Sclerosis
- Keywords
- Relapse-remitting Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 25 Apr 2018 (actual)
- 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.
The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Behavioral: ketogenic diet |
| Intermittent therapeutical fasting | Experimental | Behavioral: Intermittent therapeutical fasting |
| Control group | Active comparator | Behavioral: Active comparatorThe control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Existing health insurance, so that in case of random findings these can also be clarified
- Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010
- Age 18-65
- Consent ability and written consent
- BMI between 19 and 45 kg / m2
Key exclusion criteria (22 listed)
- Initiation or modification of immunomodulatory therapy during the study
- Cortisone treatment in the last 30 days before enrollment
- Relapse in the last 30 days before enrollment
- Insulin-dependent diabetes mellitus (type I)
- Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day
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 |
|---|---|---|
| ketogenic dietPatients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat. | Behavioural | Ketogenic diet |
| Intermittent therapeutical fastingPatients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day. | Behavioural | Intermittent therapeutical fasting |
| Active comparatorThe control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients. | Behavioural | Control group |
Primary outcome
Change in cerebral T2 lesions from Baseline at 18 months
Time frame: Change from baseline at 18 months
Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT
4 secondary outcomes
Change in neurological-functional disability: physical and cognitive function
Time frame: Change from baseline at 9 and 18 months
Change in neurological-functional disability : physical function
Time frame: Change from baseline at 9 and 18 months
annual relapse rate
Time frame: 12 months
progress of brain atrophy
Time frame: Change from baseline at 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 40836308Bahr LS, Bellmann-Strobl J, Koppold DA, Rust R, Schmitz-Hubsch T, Olszewska M, Stadlbauer J, Bock M, Scheel M, Chien C, Multmeier J, Krannich A, Michalsen A, Paul F, Mahler A. Fasting, ketogenic, and anti-inflammatory diets in multiple sclerosis: a randomized controlled trial with 18-month follow-up. BMC Nutr. 2025 Aug 20;11(1):167. doi: 10.1186/s40795-025-01156-5.
- Derived from this study: PubMed 31898518Bahr LS, Bock M, Liebscher D, Bellmann-Strobl J, Franz L, Pruss A, Schumann D, Piper SK, Kessler CS, Steckhan N, Michalsen A, Paul F, Mahler A. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9.
- Individual participant dataSharing planned: No
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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.
Friedemann Paul, Dr. med. principal investigator
Charite University, 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 ketogenic diet, Intermittent therapeutical fasting and Active comparator in people with 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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 29 Jul 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?
Results are not available in the source record.
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 in cerebral T2 lesions from Baseline at 18 months (time frame: Change from baseline at 18 months). 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 NCT03508414, which also lists 2 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 29 Jul 2021.