Multiple SclerosisEarly Phase 1FAST-MSNCT06039007
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis
A Early Phase 1 study testing 7-day Fasting-Mimicking Diet (7-DAY FMD) in people with Multiple Sclerosis, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
This study is an open-label, single-arm, run-in study in patients with RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet (FMD) over 6 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 7-day Fasting-Mimicking Diet (7-DAY FMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2019to 30 Mar 2024
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of RRMS (Thompson et al. 2018);
- Disease duration 6 months to 10 years (included);
- EDSS 0 to 4, 5;
- Treatment with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate).
Who cannot join
- < 6 months since treatment start with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate);
- Relapse < 60 days;
- Any active or chronic infection;
- Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year;
- Severely limited life expectancy by another co-morbid illness;
- Nutritional risk screening (NRS 2002) > or = 3;
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- BMI <= 18.5 kg/m2;
- Bio-impedance phase angle <5.0°;
- History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
This study is an open-label, single-arm, run-in study in patients with RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet (FMD) over 6 months. All eligible patients will receive 3 cycles of the FMD once every 60 days in addition to their standard therapy with first line therapies. The diet provides 1100kcal on day 1 and 800 kcal on days 2-7. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.
Read the detailed description
The primary objective of the present study is to evaluate the safety and tolerability of 3 cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate). The primary endpoint is the number of serious and/or severe adverse events after the FMD start. A nutritionist will follow the patients for all the 6 months period, with the aim to monitor the FMD effects and to check for any possible problems. The nutritionist will call the patient on day 1 of every FMD cycle to answer any questions and check on the response, and on day 5 of the FMD to check on side effects and adherence.
At scheduled visits, vital signs and adverse events will be recorded from every patient.
Blood samples will be collected at baseline and just before at day 7 before returning to the normal diet on cycle 1 and 1 week after the first, the second and third FMD cycles. Should the patient display abnormal counts, the CBC will be repeated one week later. Additional FMD cycles will not be allowed in patients who do not return to normal levels of White Blood Cells (WBC) and Red Blood Cells (RBC).
At scheduled visits, vital signs and adverse events will be recorded from every patient.
FMD will be administered at month 0, month 2 and month 4 (3 cycles). MRI will be done at baseline and at month 6. At baseline and at month 6 patients will be evaluated with the EDSS and MSFC Functional composite scale. At the same time points, patients will be examined for the presence of cognitive disturbances by the Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS) battery , of anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS) , of fatigue by the Modified Fatigue Impact Scale (MFIS) , while quality of life will be monitored using the Short Form 36 Health Survey (SF-36) . A nutritional assessment will be carried out at enrollment and before every FMD cycle: patients will be examined evaluating the height and weight, with determination of the BMI; the bodily composition will be measured with a dynamometer and by BIA.
Adverse events (AEs) will be monitored for each patient up to the study termination; in case of ongoing AEs at study end, patients will be followed for 30 additional days.
During the whole duration of the study, patients will be instructed to perform standardized physical exercises, in order to avoid fasting induced sarcopenia. Briefly, before each FMD cycle, patients will be recommended to exercise 30 minutes daily according to a dedicated training program to improve their muscle anabolism in the interval between the three FMD cycles.
- Conditions
- Multiple Sclerosis
- Being tested
- 7-day Fasting-Mimicking Diet (7-DAY FMD)
- Keywords
- fasting mimicking diet, 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.
7-day Fasting-Mimicking Diet (7-DAY FMD)Dietary supplement
This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day.
| Study group | Role | What they receive |
|---|---|---|
| 7-DAY FMD | Experimental | The 7-DAY FMD by L-Nutra is a low-calorie and low-protein diet that provides all the necessary micronutrients to prevent malnutrition. This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. The diet consists of ingredients that are Generally Regarded As Safe (GRAS), selected for their fasting mimicking properties. Patients will take the 7-DAY FMD once every 60 days. Receives: Dietary Supplement: 7-day Fasting-Mimicking Diet (7-DAY FMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 7-day FMD
Safety of 7-day FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status.
To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing > grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle <5° assessed with bio-impedance measurements. for Adverse Events (CTCAE)
Measured: 6 months
Secondary outcomes (6)
Percentage of patients able to achieve the designated diet regimen
Feasibility of FMD in terms of percentage of patients able to complete the diet regimen To evaluate the feasibility of the FMD in MCI and AD patients as assessed by the percentage of patients (%) able to achieve the designated diet regimen.
Measured: 6 months
Changes in the Expanded Disability Status Scale (EDSS)
Score 0-10
Measured: 6 months
Changes in Body Mass Index (BMI)
kg/m2
Measured: 6 months
Changes in the serum light chain neurofilaments concentration
ng/ml
Measured: 6 months
White Blood Cells
mil/mm3
Measured: 6 months
Efficacy of the FMD in terms of nutritional state
Efficacy of the FMD in terms of nutritional state will be assessed with phase angle with bioimpedance (°)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start16 Dec 2019
- Primary completion31 Jul 2023
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039007
- Sponsor's protocol ID
- FAST-MS
- Acronym
- FAST-MS
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
- ClinicalTrials.gov ID
- NCT06039007
- Acronym / sponsor ID
- FAST-MS / FAST-MS
- Conditions
- Multiple Sclerosis
- Keywords
- fasting mimicking diet, multiple sclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 Sep 2023 (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.
This study is an open-label, single-arm, run-in study in patients with RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet (FMD) over 6 months. All eligible patients will receive 3 cycles of the FMD once every 60 days in addition to their standard therapy with first line therapies. The diet provides 1100kcal on day 1 and 800 kcal on days 2-7. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.
Detailed description
The primary objective of the present study is to evaluate the safety and tolerability of 3 cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate). The primary endpoint is the number of serious and/or severe adverse events after the FMD start. A nutritionist will follow the patients for all the 6 months period, with the aim to monitor the FMD effects and to check for any possible problems. The nutritionist will call the patient on day 1 of every FMD cycle to answer any questions and check on the response, and on day 5 of the FMD to check on side effects and adherence.
At scheduled visits, vital signs and adverse events will be recorded from every patient.
Blood samples will be collected at baseline and just before at day 7 before returning to the normal diet on cycle 1 and 1 week after the first, the second and third FMD cycles. Should the patient display abnormal counts, the CBC will be repeated one week later. Additional FMD cycles will not be allowed in patients who do not return to normal levels of White Blood Cells (WBC) and Red Blood Cells (RBC).
At scheduled visits, vital signs and adverse events will be recorded from every patient.
FMD will be administered at month 0, month 2 and month 4 (3 cycles). MRI will be done at baseline and at month 6. At baseline and at month 6 patients will be evaluated with the EDSS and MSFC Functional composite scale. At the same time points, patients will be examined for the presence of cognitive disturbances by the Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS) battery , of anxiety and depressive symptoms by the Hospital Anxiety and Depression Scale (HADS) , of fatigue by the Modified Fatigue Impact Scale (MFIS) , while quality of life will be monitored using the Short Form 36 Health Survey (SF-36) . A nutritional assessment will be carried out at enrollment and before every FMD cycle: patients will be examined evaluating the height and weight, with determination of the BMI; the bodily composition will be measured with a dynamometer and by BIA.
Adverse events (AEs) will be monitored for each patient up to the study termination; in case of ongoing AEs at study end, patients will be followed for 30 additional days.
During the whole duration of the study, patients will be instructed to perform standardized physical exercises, in order to avoid fasting induced sarcopenia. Briefly, before each FMD cycle, patients will be recommended to exercise 30 minutes daily according to a dedicated training program to improve their muscle anabolism in the interval between the three FMD cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7-DAY FMD | Experimental | Dietary Supplement: 7-day Fasting-Mimicking Diet (7-DAY FMD)The 7-DAY FMD by L-Nutra is a low-calorie and low-protein diet that provides all the necessary micronutrients to prevent malnutrition. This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. The diet consists of ingredients that are Generally Regarded As Safe (GRAS), selected for their fasting mimicking properties. Patients will take the 7-DAY FMD once every 60 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of RRMS (Thompson et al. 2018);
- Disease duration 6 months to 10 years (included);
- EDSS 0 to 4, 5;
- Treatment with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate).
Key exclusion criteria (9 listed)
- < 6 months since treatment start with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl fumarate);
- Relapse < 60 days;
- Any active or chronic infection;
- Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year;
- Severely limited life expectancy by another co-morbid illness;
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 |
|---|---|---|
| 7-day Fasting-Mimicking Diet (7-DAY FMD)This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. | Dietary supplement | 7-DAY FMD |
Primary outcome
Safety and tolerability of 7-day FMD
Time frame: 6 months
Safety of 7-day FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status. To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing > grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle <5° assessed with bio-impedance measurements. for Adverse Events (CTCAE)
6 secondary outcomes
Percentage of patients able to achieve the designated diet regimen
Time frame: 6 months
Changes in the Expanded Disability Status Scale (EDSS)
Time frame: 6 months
Changes in Body Mass Index (BMI)
Time frame: 6 months
Changes in the serum light chain neurofilaments concentration
Time frame: 6 months
White Blood Cells
Time frame: 6 months
Efficacy of the FMD in terms of nutritional state
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 7-day Fasting-Mimicking Diet (7-DAY FMD) in people with Multiple Sclerosis, run by Ospedale Policlinico San Martino at 1 site in Italy.
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 4 inclusion and 9 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 4 Oct 2023. 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 Italy. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and tolerability of 7-day FMD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.