Intermittent Fasting in Multiple Sclerosis

NCT03539094 | Completed

• 1 other identifier: 201707010
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Intermittent fasting; western diet; microbiome

Outcome Measures

Primary Outcomes (1)

• Leptin

  Leptin at week 12 measured in the peripheral blood

  12 weeks

Secondary Outcomes (4)

• Peripheral metabolic and inflammatory profiling

  12 weeks

• Anthropometric measure

  12 weeks

• Anthropometric measure

  12 weeks

• Gut microbiota

  12 weeks

Study Arms (2)

Intermittent fasting

EXPERIMENTAL

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

Western diet

NO INTERVENTION

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

Interventions

Intermittent fasting OTHER

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.

Intermittent fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Ghezzi L, Tosti V, Shi L, Cantoni C, Mikesell R, Lancia S, Zhou Y, Obert K, Dula C, Sen MK, Ge A, Tolentino M, Bollman B, Don AS, Matarese G, Colamatteo A, La Rocca C, Lepore MT, Raji CA, Rahmani F, Wu GF, Naismith RT, Fontana L, Cross AH, Salter A, Piccio L. Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2025 Jan 16;96(2):158-169. doi: 10.1136/jnnp-2024-333465.

  PMID: 39137977 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Intermittent Fasting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the intervention because they will not know the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 29, 2018
• Study Start: January 1, 2018
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)