A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Other: Diet
- Registration Number
- NCT02647502
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent calorie restriction Diet 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. Control calorie intake Diet Participants will be assigned to consume enough calories each day required to maintain current BMI Continuous calorie restriction Diet Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.
- Primary Outcome Measures
Name Time Method Adverse events 8 weeks Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
- Secondary Outcome Measures
Name Time Method NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire 48 weeks PROMIS Fatigue results will be assessed during the study
Quality of Life Questionnaire 48 weeks "Functional Assessment in MS" results will be assessed during the study
Change in concentration of measures of metabolism 8 weeks The impact of each calorie restriction diet versus control diet on fasting glucose, insulin, leptin, ghrelin, C-reactive protein, lipids, and long-chain ceramides will be assessed.
Adverse Events 48 weeks Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
Change in metabolite ratios 8 weeks The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
Change in serum brain-derived neurotrophic factor concentration (BDNF) 8 weeks The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
Adherence to Calories Assigned 48 weeks Adherence during the "advice-only" phase will be compared to adherence in each diet group during the first 8 weeks using paired t-tests, where the grouping is done naturally by subject.
Immune cell subsets/cytokines 8 weeks The impact of each calorie restriction diet versus control diet on ratios of immune cell subsets (e.g. T-helper (TH)17, TH1, TH2, T regulatory) and related cytokines will be assessed.
Change in serum lipid concentration 8 weeks The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
Change in levels of oxidative stress biomarkers 8 weeks The impact of each calorie restriction diet versus control diet on protein carbonyls, 8-isoprostane, nitrotyrosine, and 4-hydroxynonenal adducts will be assessed.
Trial Locations
- Locations (1)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States