Intermittent Fasting in Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— IFMS  

Official title:

Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539094
• Other study ID #: 201707010
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University in St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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