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A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis

14. november 2017 opdateret af: Ellen M. Mowry, Johns Hopkins University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Eksperimentel: 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.
Andet: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Placebo komparator: Control calorie intake
Participants will be assigned to consume enough calories each day required to maintain current BMI
Andet: Diet
Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: 8 weeks
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence to Calories Assigned
Tidsramme: 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.
8 weeks
Adherence to Calories Assigned
Tidsramme: 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.
48 weeks
Adverse Events
Tidsramme: 48 weeks
Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
48 weeks
Quality of Life Questionnaire
Tidsramme: 48 weeks
"Functional Assessment in MS" results will be assessed during the study
48 weeks
NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
Tidsramme: 48 weeks
PROMIS Fatigue results will be assessed during the study
48 weeks
Change in metabolite ratios
Tidsramme: 8 weeks
The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
8 weeks
Immune cell subsets/cytokines
Tidsramme: 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 weeks
Change in concentration of measures of metabolism
Tidsramme: 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.
8 weeks
Change in serum lipid concentration
Tidsramme: 8 weeks
The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
8 weeks
Change in serum brain-derived neurotrophic factor concentration (BDNF)
Tidsramme: 8 weeks
The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
8 weeks
Change in levels of oxidative stress biomarkers
Tidsramme: 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.
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins University

Efterforskere

  • Ledende efterforsker: Ellen Mowry, MD, Johns Hopkins University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

28. december 2015

Først indsendt, der opfyldte QC-kriterier

4. januar 2016

Først opslået (Skøn)

6. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00065806

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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