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Completed

NCT Number: NCT02647502

A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Quality of Life Questionnaire

    Time frame: 48 weeks

    "Functional Assessment in MS" results will be assessed during the study

  5. NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire

    Time frame: 48 weeks

    PROMIS Fatigue results will be assessed during the study

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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