A run-in Study on the Safety and Tolerability of a Fasting Mimicking D
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- 7-day Fasting-Mimicking Diet (7-DAY FMD)
What it measured
Main measures
Safety and tolerability of 7-day FMD
6 months
Safety
Other measures (6)
Percentage of patients able to achieve the designated diet regimen
6 months
FeasibilityChanges in the Expanded Disability Status Scale (EDSS)
6 months
Disability progressionChanges in Body Mass Index (BMI)
6 months
Changes in the serum light chain neurofilaments concentration
6 months
Blood or spinal fluid markersWhite Blood Cells
6 months
Efficacy of the FMD in terms of nutritional state
6 months
Who could take part
Relapsing MS · 18 to 50 · EDSS 0 to 4
Show the full criteria
Inclusion criteria
* 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).
Exclusion criteria
* \< 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; * 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;
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Dec 2019
Main results due
Jul 2023
Finished
Mar 2024