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Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease

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Stanford University

Status

Active, not recruiting

Conditions

Diet Modification
Inflammatory Bowel Diseases
Crohn Disease

Treatments

Other: Intermittent Reduced Calorie Diet (IRCD)

Study type

Interventional

Funder types

Other

Identifiers

NCT04147585
IRB 53161

Details and patient eligibility

About

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.

Full description

As above

Enrollment

86 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mild to moderate Crohn's disease (CDAI score 151-450)
  • Between the ages of 18-70 (inclusive)

Exclusion criteria

  • 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Intervention Arm
Experimental group
Description:
Three cycles of a 5-day Intermittent Reduced Calorie Diet
Treatment:
Other: Intermittent Reduced Calorie Diet (IRCD)
Control Arm
No Intervention group
Description:
Regular Diet

Trial contacts and locations

1

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Central trial contact

Touran Fardeen

Data sourced from clinicaltrials.gov

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