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Intermittent Fasting in Multiple Sclerosis (IFMS)

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intermittent fasting

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Intermittent fasting, western diet, microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University in St Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intermittent fasting

Western diet

Arm Description

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.

The subjects randomized to this group will eat a standard western style diet.

Outcomes

Primary Outcome Measures

Leptin

Leptin at week 12 measured in the peripheral blood

Secondary Outcome Measures

Peripheral metabolic and inflammatory profiling

Adipokine and inflammatory markers at week 12 measured in the peripheral blood

Anthropometric measure

Weight and height will be combined to report BMI in kg/mg^2

Anthropometric measure

Waist circumference in centimeters

Gut microbiota

Gut microbiota richness and composition

Full Information

NCT ID

NCT03539094

First Posted

April 27, 2018

Last Updated

April 25, 2022

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03539094

Brief Title

Intermittent Fasting in Multiple Sclerosis

Acronym

IFMS

Official Title

Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

January 20, 2022 (Actual)

Study Completion Date

January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Intermittent fasting, western diet, microbiome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled clinical trial

Masking

Outcomes Assessor

Masking Description

Outcome assessors will be blinded to the intervention because they will not know the group assignment.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent fasting

Arm Type

Experimental

Arm Description

Arm Title

Western diet

Arm Type

No Intervention

Arm Description

The subjects randomized to this group will eat a standard western style diet.

Intervention Type

Other

Intervention Name(s)

Intermittent fasting

Intervention Description

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.

Primary Outcome Measure Information:

Title

Leptin

Description

Leptin at week 12 measured in the peripheral blood

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Peripheral metabolic and inflammatory profiling

Description

Adipokine and inflammatory markers at week 12 measured in the peripheral blood

Time Frame

12 weeks

Title

Anthropometric measure

Description

Weight and height will be combined to report BMI in kg/mg^2

Time Frame

12 weeks

Title

Anthropometric measure

Description

Waist circumference in centimeters

Time Frame

12 weeks

Title

Gut microbiota

Description

Gut microbiota richness and composition

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Washington University in St Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared with other researchers.

Learn more about this trial

Intermittent Fasting in Multiple Sclerosis

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