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A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

NCT ID: NCT02647502

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous calorie restriction

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

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type OTHER

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

Intermittent calorie restriction

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.

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

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

Control calorie intake

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

Group Type PLACEBO_COMPARATOR

Diet

Intervention Type OTHER

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

Interventions

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Diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Ellen M. Mowry

Associate Professor of Neurology and Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Mowry, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00065806

Identifier Type: -

Identifier Source: org_study_id