Clinical trial NCT02647502: A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Official title: A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Adherence to Calories Assigned
timeFrame: 8 weeks
measure: Adherence to Calories Assigned
timeFrame: 48 weeks
measure: Adverse Events
timeFrame: 48 weeks
measure: Quality of Life Questionnaire
timeFrame: 48 weeks
measure: NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
timeFrame: 48 weeks
measure: Change in metabolite ratios
timeFrame: 8 weeks
measure: Immune cell subsets/cytokines
timeFrame: 8 weeks
measure: Change in concentration of measures of metabolism
timeFrame: 8 weeks
measure: Change in serum lipid concentration
timeFrame: 8 weeks
measure: Change in serum brain-derived neurotrophic factor concentration (BDNF)
timeFrame: 8 weeks
measure: Change in levels of oxidative stress biomarkers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ellen Mowry, MD
role: PRINCIPAL_INVESTIGATOR
References: