Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515782
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-04
Brief Title:
Effect of a Fasting Mimicking Diet on Patients With Multiple Sclerosis FMDMS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Fasting Mimicking Diet on Measures of Inflammatory Disease in Relapsing Multiple Sclerosis RMS Patients Treated With Standard Disease Modifying Therapies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMDMS
Brief Summary:
In the proposed study investigators will assess the safety and feasibility of cycles of a fasting mimicking diet FMD and its effect on Multiple Sclerosis Quality of Life MSQOL in relapsing MS RMS patients treated with standard disease modifying therapies FMDMS
To test the primary hypothesis investigators will compare the composite quality of life score in terms of improvement in disability fatigue and cognitive function with the fasting protocol as compared to a Mediterranean diet control group alone Further investigators hypothesize that the effects will remain for at least 6-months after the last FMD cycle The Mediterranean diet MD has been chosen as the control diet to minimize baseline dietary differences among patients It has been trialed for feasibility in Multiple Sclerosis patients and used in a previous human FMD trial for MS patients where a FMD followed by MD was shown to have positive effects on people with MS
To test the primary hypothesis investigators will compare the composite quality of life score in terms of improvement in disability fatigue and cognitive function with the fasting protocol as compared to a Mediterranean diet control group alone Further investigators hypothesize that the effects will remain for at least 6-months after the last FMD cycle The Mediterranean diet MD has been chosen as the control diet to minimize baseline dietary differences among patients It has been trialed for feasibility in Multiple Sclerosis patients and used in a previous human FMD trial for MS patients where a FMD followed by MD was shown to have positive effects on people with MS
Detailed Description:
The study design is a cross-over randomized controlled trial that includes two arms in which all patients will be on a MD for twelve months One group will be on MD alone for 6 months and then do 3 rounds of a standardized 7-day FMD dietary regimen every 2 months The other group will do the 3 cycles of FMD during the first 6 months and the subsequent 6 months on the MD alone This will allow investigators to test FMD effects on a defined background diet as well as tease out the effects of that diet alone In addition investigators will be able to assess long term effects of a FMD on an autoimmune disease
Preliminary data from a phase I clinical study in MS suggest that a FMD is safe feasible and potentially effective in relapsing-remitting multiple sclerosis RRMS patients registered in Clinical Trials ID NCT01538355 This study demonstrated a positive effect on health-related quality of life HRQOL components and a small effect on disability after one round FMD followed by a Mediterranean diet for 5 months
A successful trial will provide relevant information about the efficacy and safety of these dietary interventions in MS patients and help confirm the positive effects seen in previous studies In addition it is designed to elucidate the physiologic and immunologic effects of dietary changes and could help clarify the complex interactions between nutrition and autoimmune disease
Preliminary data from a phase I clinical study in MS suggest that a FMD is safe feasible and potentially effective in relapsing-remitting multiple sclerosis RRMS patients registered in Clinical Trials ID NCT01538355 This study demonstrated a positive effect on health-related quality of life HRQOL components and a small effect on disability after one round FMD followed by a Mediterranean diet for 5 months
A successful trial will provide relevant information about the efficacy and safety of these dietary interventions in MS patients and help confirm the positive effects seen in previous studies In addition it is designed to elucidate the physiologic and immunologic effects of dietary changes and could help clarify the complex interactions between nutrition and autoimmune disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None