Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039007
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-08
Brief Title:
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis
Sponsor:
Ospedale Policlinico San Martino
Organization:
Ospedale Policlinico San Martino
Study Overview
Official Title:
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis FAST-MS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST-MS
Brief 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 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None