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

NCT06039007 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

7-day Fasting-Mimicking Diet (7-DAY FMD)

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.

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2023-07-31
Completion
2024-03-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039007 on ClinicalTrials.gov