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A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02647502
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ellen M. Mowry, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 28, 2015
First Posted Date  ICMJE January 6, 2016
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Official Title  ICMJE A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE Other: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Diet
  • 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.
    Intervention: Other: Diet
  • Placebo Comparator: Control calorie intake
    Participants will be assigned to consume enough calories each day required to maintain current BMI
    Intervention: Other: Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02647502
Other Study ID Numbers  ICMJE IRB00065806
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ellen M. Mowry, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ellen Mowry, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP