NCT02647502

A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also associated with less severe disease in mice who do develop the disease. Currently, whether these results translate favorably in humans is unknown. This is a pilot trial of testing two caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one continuous caloric restriction (CR) diet where a small number of calories will be restricted every day or another intermittent CR diet where a caloric intake will be restricted more severely 2 days per week. Participants are randomized to one of the diets, and for the first 8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the conclusion of the controlled feeding study, all participants will transition to an unblinded phase for an additional 40 weeks where they are provided with instructions to follow an intermittent CR diet.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Diet	Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-01-06
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States