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A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
7-day Fasting-Mimicking Diet (7-DAY FMD)
Sponsored by
Ospedale Policlinico San Martino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring fasting mimicking diet, multiple sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Ospedale San Martino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

7-DAY FMD

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Changes in the Expanded Disability Status Scale (EDSS)
Score 0-10
Changes in Body Mass Index (BMI)
kg/m2
Changes in the serum light chain neurofilaments concentration
ng/ml
White Blood Cells
mil/mm3
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 (°)

Full Information

First Posted
September 8, 2023
Last Updated
October 2, 2023
Sponsor
Ospedale Policlinico San Martino
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1. Study Identification

Unique Protocol Identification Number
NCT06039007
Brief Title
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis
Acronym
FAST-MS
Official Title
A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ospedale Policlinico San Martino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
fasting mimicking diet, multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7-DAY FMD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
7-day Fasting-Mimicking Diet (7-DAY FMD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability of 7-day FMD
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of patients able to achieve the designated diet regimen
Description
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.
Time Frame
6 months
Title
Changes in the Expanded Disability Status Scale (EDSS)
Description
Score 0-10
Time Frame
6 months
Title
Changes in Body Mass Index (BMI)
Description
kg/m2
Time Frame
6 months
Title
Changes in the serum light chain neurofilaments concentration
Description
ng/ml
Time Frame
6 months
Title
White Blood Cells
Description
mil/mm3
Time Frame
6 months
Title
Efficacy of the FMD in terms of nutritional state
Description
Efficacy of the FMD in terms of nutritional state will be assessed with phase angle with bioimpedance (°)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Ospedale San Martino
City
Genova
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis

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