Overview

This trial is active, not recruiting.

Condition relapsing remitting multiple sclerosis
Treatment diet
Phase phase 1
Sponsor Johns Hopkins University
Start date December 2015
End date March 2017
Trial size 36 participants
Trial identifier NCT02647502, IRB00065806

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants will be provided with a diet that includes approximately 78% of calories each day that would be needed to maintain current BMI.
diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
(Experimental)
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.
diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
(Placebo Comparator)
Participants will be assigned to consume enough calories each day required to maintain current BMI
diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

Primary Outcomes

Measure
Adverse events
time frame: 8 weeks

Secondary Outcomes

Measure
Adherence to Calories Assigned
time frame: 8 weeks
Adherence to Calories Assigned
time frame: 48 weeks
Adverse Events
time frame: 48 weeks
Quality of Life Questionnaire
time frame: 48 weeks
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
time frame: 48 weeks
Change in metabolite ratios
time frame: 8 weeks
Immune cell subsets/cytokines
time frame: 8 weeks
Change in concentration of measures of metabolism
time frame: 8 weeks
Change in serum lipid concentration
time frame: 8 weeks
Change in serum brain-derived neurotrophic factor concentration (BDNF)
time frame: 8 weeks
Change in levels of oxidative stress biomarkers
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Principal investigator Ellen Mowry, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.