A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
14 novembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adverse events
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adherence to Calories Assigned
Délai: 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
Délai: 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.
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48 weeks
|
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Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 8 weeks
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The impact of each calorie restriction diet versus control diet on fasting BDNF will be assessed.
|
8 weeks
|
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Change in levels of oxidative stress biomarkers
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ellen Mowry, MD, Johns Hopkins University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2015
Achèvement primaire (Réel)
1 juin 2017
Achèvement de l'étude (Réel)
1 juin 2017
Dates d'inscription aux études
Première soumission
28 décembre 2015
Première soumission répondant aux critères de contrôle qualité
4 janvier 2016
Première publication (Estimation)
6 janvier 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 novembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 novembre 2017
Dernière vérification
1 novembre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00065806
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