A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
14 november 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
36
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adverse events
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adherence to Calories Assigned
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 48 weeks
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PROMIS Fatigue results will be assessed during the study
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48 weeks
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Change in metabolite ratios
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ellen Mowry, MD, Johns Hopkins University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2015
Primaire voltooiing (Werkelijk)
1 juni 2017
Studie voltooiing (Werkelijk)
1 juni 2017
Studieregistratiedata
Eerst ingediend
28 december 2015
Eerst ingediend dat voldeed aan de QC-criteria
4 januari 2016
Eerst geplaatst (Schatting)
6 januari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 november 2017
Laatste update ingediend die voldeed aan QC-criteria
14 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00065806
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .