Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.
Official Title
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
Eligibility Criteria
- - Mild to moderate Crohn's disease (CDAI score 151-450) - Between the ages of 18-70 (inclusive)
- - Women who are pregnant, nursing or expect to be pregnant - Individuals allergic to nuts - Individuals with a body mass index (BMI) lower than 18 - Individuals diagnosed with a serious medical condition (unless approved in writing by a physician) - Individuals who have been severely weakened by a disease or medical procedure - Individuals who are taking medication which may not be safely consumed with a calorie restricted diet - Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia - Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician - Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%) - Individuals with a history of syncope - Individuals with dietary needs incompatible with the IRCD meal plan - Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet - Patients on a calorie restricted diet will also be excluded - Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine,total colectomy, proctocolectomy, ileoanal pouch will be excluded (not excluded are patients with resection of terminal ileum, resection of short strictures of the small intestine, hemicolectomy).
Investigator(s)
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Contact
Touran Fardeen
View on ClinicalTrials.gov
