Intermittent Fasting in Multiple Sclerosis (IFMS)

Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis

This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in RRMS patients. This is a single-center study.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Other: Intermittent fasting

Detailed Description

RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which IF will be compared to a standard western diet. Patients will be recruited at the John L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet (1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of RRMS (2010 Mc Donald criteria).
• EDSS <6.0 and disease duration ≤ 15 years.
• On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
• Age ≥18 years.
• BMI > 22 and < 35 kg/m2 with stable weight in the 3 months prior to screening.

Exclusion Criteria:

• History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
• Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
• Relapsing at the time of enrollment.
• On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
• Diagnosis of diabetes or at time of OGTT (fasting glucose >126 mg/dl or > 200 mg/dl at 2 hours with a load of 75 g of glucose
• History of food allergies or food intolerance that would interfere with the study.
• History of antibiotic treatment within the past 3 months prior to enrollment
• Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their intake of vegetables containing high levels of vitamin K.
• Currently on a special diet and not willing to stop at least one month prior to enrollment
• Currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment
• Currently pregnant or plan to become pregnant within 6 months
• Current tobacco or e-cigarette smoker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent fasting; The subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables.	Other: Intermittent fasting; the subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables.
No Intervention: Western diet; The subjects randomized to this group will eat a standard western style diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leptin	Leptin at week 12 measured in the peripheral blood	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral metabolic and inflammatory profiling	Adipokine and inflammatory markers at week 12 measured in the peripheral blood	12 weeks
Anthropometric measure	Weight and height will be combined to report BMI in kg/mg^2	12 weeks
Anthropometric measure	Waist circumference in centimeters	12 weeks
Gut microbiota	Gut microbiota richness and composition	12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; western diet; microbiome; Intermittent fasting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 201707010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No