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Completed

NCT Number: NCT04147585

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

The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting (also known as a fasting mimicking diet, FMD) 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.

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Key information

Conditions

Inflammatory Bowel Diseases Behavior Crohn Disease Diet Modification Digestive System Diseases Fasting Feeding Behavior Gastroenteritis Gastrointestinal Diseases Intermittent Fasting Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intermittent Reduced Calorie Diet (IRCD)

Other

Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.

Primary outcomes

  1. Number of Participants with Clinical response as per CDAI (70 points)

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.

Secondary outcomes

  1. Number of Participants with Clinical remission as per CDAI

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as a CDAI score ≤ 150.

  2. Number of Participants with Clinical response as per CDAI (100 points)

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.

  3. Number of Participants with Clinical response as per CDAI (70 points)

    Time frame: Assessed 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.

  4. Change in C-reactive protein (CRP) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

    Time frame: Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Change of the inflammatory marker CRP.

  5. Change in Erythrocyte Sedimentation Rate (ESR) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

    Time frame: Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Change of the inflammatory marker ESR.

  6. Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

    Time frame: Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Change of the inflammatory marker fecal calprotectin.

  7. Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as average worst daily abdominal pain score of ≤ 1 (using a 4-point scale, 0-3) and a loose/watery stool (Bristol Type 6 or 7) frequency score of <=3.

  8. Patient global assessment

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    "Do you believe you are in remission from your CD symptoms?" (Yes/No). No scale.

  9. Effect of IRCD on endoscopic outcomes

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Changes in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD). SES-CD scores range from 0 to 56 and higher scores indicate more severe disease.

  10. Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)

    Time frame: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).

Other outcomes

  1. Number of Participants with Clinical remission as per CDAI

    Time frame: Assessed 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as a CDAI score ≤ 150.

  2. Number of Participants with Clinical response as per CDAI (100 points)

    Time frame: Assessed 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.

  3. Changes in clinical markers of disease activity

    Time frame: At baseline versus 3 months after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Clinical markers of disease activity are CRP, ESR, and fecal calprotectin.

  4. Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)

    Time frame: Assessed 3 months after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).

  5. Changes in clinical markers of disease activity

    Time frame: At baseline versus within 6 days after 1st cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Clinical markers of disease activity are CRP, ESR, and fecal calprotectin.

  6. Changes in cytokines/chemokines and immune cell profiles

    Time frame: At baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Using flow cytometry and mass cytometry (CyTOF)

  7. Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics)

    Time frame: At baseline versus within 6 days after 3rd cycle of IRCD and 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

    Gut metabolites include short-chain fatty acid and bile acid profiles.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2019
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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