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

NCT06039007 | Unknown Early Phase 1

• 1 other identifier: FAST-MS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

fasting mimicking diet; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (6)

• Percentage of patients able to achieve the designated diet regimen

  6 months

• Changes in the Expanded Disability Status Scale (EDSS)

  6 months

• Changes in Body Mass Index (BMI)

  6 months

• Changes in the serum light chain neurofilaments concentration

  6 months

• White Blood Cells

  6 months

Study Arms (1)

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.

Dietary Supplement: 7-day Fasting-Mimicking Diet (7-DAY FMD)

Interventions

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.

7-DAY FMD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• \< 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;

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Ospedale San Martino

Genova, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: December 16, 2019
• Primary Completion: July 31, 2023
• Study Completion: March 30, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

IT (1)