Intermittent Fasting in Multiple Sclerosis

NCT ID: NCT03539094

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-01-20

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intermittent fasting

Intervention Type: 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.

Western diet

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University in St Louis

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39137977 (View on PubMed)

Other Identifiers

201707010

Identifier Type: -

Identifier Source: org_study_id