Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Intermittent Fasting in Multiple Sclerosis (IFMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539094
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Other: Intermittent fasting Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to the intervention because they will not know the group assignment.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Leptin [ Time Frame: 12 weeks ]
    Leptin at week 12 measured in the peripheral blood


Secondary Outcome Measures :
  1. Peripheral metabolic and inflammatory profiling [ Time Frame: 12 weeks ]
    Adipokine and inflammatory markers at week 12 measured in the peripheral blood

  2. Anthropometric measure [ Time Frame: 12 weeks ]
    Weight and height will be combined to report BMI in kg/mg^2

  3. Anthropometric measure [ Time Frame: 12 weeks ]
    Waist circumference in centimeters

  4. Gut microbiota [ Time Frame: 12 weeks ]
    Gut microbiota richness and composition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539094


Contacts
Layout table for location contacts
Contact: Laura Piccio, MD, PhD 3147474591 picciol@wustl.edu
Contact: Valeria Tosti, MD 314-362-2394 vtosti@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Laura Piccio, MD, PhD    314-747-4591    picciol@neuro.wustl.edu   
Contact: Valeria Tosti, MD    314-362-2394    vtosti@wustl.edu   
Principal Investigator: Laura Piccio, MD, PhD         
Sponsors and Collaborators
Washington University School of Medicine

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03539094    
Other Study ID Numbers: 201707010
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Multiple Sclerosis
Intermittent fasting
western diet
microbiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases