This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ellen M. Mowry, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02647502
First received: December 28, 2015
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Other: Diet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Ellen M. Mowry, Johns Hopkins University:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 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:
  • Adherence to Calories Assigned [ Time Frame: 8 weeks ]
    Adherence will be assessed by comparing the total caloric intake provided to the patients through the assigned diet to the total energy intake determined by the research dieticians.

  • Adherence to Calories Assigned [ Time Frame: 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.

  • Adverse Events [ Time Frame: 48 weeks ]
    Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.

  • Quality of Life Questionnaire [ Time Frame: 48 weeks ]
    "Functional Assessment in MS" results will be assessed during the study

  • NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire [ Time Frame: 48 weeks ]
    PROMIS Fatigue results will be assessed during the study

  • Change in metabolite ratios [ Time Frame: 8 weeks ]
    The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.

  • Immune cell subsets/cytokines [ Time Frame: 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 concentration of measures of metabolism [ Time Frame: 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.

  • Change in serum lipid concentration [ Time Frame: 8 weeks ]
    The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.

  • Change in serum brain-derived neurotrophic factor concentration (BDNF) [ Time Frame: 8 weeks ]
    The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.

  • Change in levels of oxidative stress biomarkers [ Time Frame: 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.


Estimated Enrollment: 36
Study Start Date: December 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Experimental: 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.
Other: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Placebo Comparator: Control calorie intake
Participants will be assigned to consume enough calories each day required to maintain current BMI
Other: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02647502

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ellen Mowry, MD Johns Hopkins University
  More Information

Responsible Party: Ellen M. Mowry, Associate Professor of Neurology and Epidemiology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02647502     History of Changes
Other Study ID Numbers: IRB00065806
Study First Received: December 28, 2015
Last Updated: March 6, 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017