A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Johns Hopkins University

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02647502

IRB00065806

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-50
• Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
• Meets 2010 criteria for McDonald MS;
• Relapse or new lesion in previous 2 years
• Expanded disability status score (EDSS) < 6
• Disease duration ≤15 years
• Untreated or on stable on first-line MS therapy [injectable] for at least 6 months, with no anticipated changes in the next 10 weeks
• Unchanged vitamin D dose or thyroid replacement dose (for those on it) with no anticipated changes or in supplement use for the next 10 weeks.
• Non-regular smoker (average no more than 1 cigarette/day) for at least 2 months
• Stable weight, by self report, for past 3 months (± 8 lbs)
• Body mass index (BMI) > 23 kg/m2

Exclusion criteria

• Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)

  • History of gastrointestinal disease causing malabsorption
  • History of diabetes requiring medication
  • History of stage IV/V chronic kidney disease or vascular disease
  • History of major surgery in past 3 months
  • Current use of warfarin
  • History of eating disorder
  • Currently on a special diet for MS/other diet (provided diet will be pork free)
  • Chemotherapy within the past year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups, including a placebo group

Continuous calorie restriction

Active Comparator group

Description:

Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.

Treatment:

Other: Diet

Intermittent calorie restriction

Experimental group

Description:

Participants will be provided a diet that with a daily calorie intake required to maintain current BMI, except only 25% of this calorie intake will be provided for 2 days a week.

Treatment:

Other: Diet

Control calorie intake

Placebo Comparator group

Description:

Participants will be assigned to consume enough calories each day required to maintain current BMI

Treatment:

Other: Diet