A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
14. november 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
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Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
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Eksperimentell: 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.
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Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
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Placebo komparator: Control calorie intake
Participants will be assigned to consume enough calories each day required to maintain current BMI
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Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adverse events
Tidsramme: 8 weeks
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Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adherence to Calories Assigned
Tidsramme: 8 weeks
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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.
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8 weeks
|
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Adherence to Calories Assigned
Tidsramme: 48 weeks
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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.
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48 weeks
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Adverse Events
Tidsramme: 48 weeks
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Adverse events will be categorized by organ system and by the blinded neurologist's assessment of the relation to the diet.
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48 weeks
|
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Quality of Life Questionnaire
Tidsramme: 48 weeks
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"Functional Assessment in MS" results will be assessed during the study
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48 weeks
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NIH Patient-Reported-Outcomes Measurement Information System (PROMIS )Fatigue Questionnaire
Tidsramme: 48 weeks
|
PROMIS Fatigue results will be assessed during the study
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48 weeks
|
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Change in metabolite ratios
Tidsramme: 8 weeks
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The impact of each calorie restriction diet versus control diet on the metabolomics profile will be assessed.
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8 weeks
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Immune cell subsets/cytokines
Tidsramme: 8 weeks
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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.
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8 weeks
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Change in concentration of measures of metabolism
Tidsramme: 8 weeks
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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.
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8 weeks
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Change in serum lipid concentration
Tidsramme: 8 weeks
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The impact of each calorie restriction diet versus control diet on fasting lipids and long-chain ceramides will be assessed.
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8 weeks
|
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Change in serum brain-derived neurotrophic factor concentration (BDNF)
Tidsramme: 8 weeks
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The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
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8 weeks
|
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Change in levels of oxidative stress biomarkers
Tidsramme: 8 weeks
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The impact of each calorie restriction diet versus control diet on protein carbonyls, 8-isoprostane, nitrotyrosine, and 4-hydroxynonenal adducts will be assessed.
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8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ellen Mowry, MD, Johns Hopkins University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2015
Primær fullføring (Faktiske)
1. juni 2017
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
28. desember 2015
Først innsendt som oppfylte QC-kriteriene
4. januar 2016
Først lagt ut (Anslag)
6. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00065806
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .