A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosi

A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT02647502

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Diet

What it measured

Main measures

  • Adverse events

    8 weeks

    Safety

Other measures (11)

  • Adherence to Calories Assigned

    8 weeks

    Quality of life (reported by participants)

  • Adherence to Calories Assigned

    48 weeks

    Quality of life (reported by participants)

  • Adverse Events

    48 weeks

    Safety

  • Quality of Life Questionnaire

    48 weeks

    Quality of life (reported by participants)

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

    48 weeks

    FatigueQuality of life (reported by participants)

  • Change in metabolite ratios

    8 weeks

  • Immune cell subsets/cytokines

    8 weeks

    Immune response

  • Change in concentration of measures of metabolism

    8 weeks

  • Change in serum lipid concentration

    8 weeks

  • Change in serum brain-derived neurotrophic factor concentration (BDNF)

    8 weeks

Who could take part

Relapsing MS · 18 to 50

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Dec 2015

    2. Main results due

      Jun 2017

    3. Finished

      Jun 2017

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