A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/18/2017 |
| Start Date: | December 2015 |
| End Date: | June 2017 |
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Ellen M Mowry, MD, MCR
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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