Inflammatory Bowel DiseasesNCT04147585
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
A study testing Intermittent Reduced Calorie Diet (IRCD) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Stanford University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Diet Modification
- What is being tested?
- Intermittent Reduced Calorie Diet (IRCD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate Crohn's disease (CDAI score 151-450)
- Between the ages of 18-70 (inclusive)
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
As above
- Being tested
- Intermittent Reduced Calorie Diet (IRCD)
- Keywords
- IBD, Crohn's disease, Diet, Fasting, Intermittent Reduced Calorie Diet, CD, intermittent fasting, FMD
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Reduced Calorie Diet (IRCD)Other
Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Three cycles of a 5-day Intermittent Reduced Calorie Diet Receives: Other: Intermittent Reduced Calorie Diet (IRCD) |
| Control Arm | No intervention | Regular Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinical response as per CDAI (70 points)
Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
Measured: 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.
Secondary outcomes (10)
Number of Participants with Clinical remission as per CDAI
Defined as a CDAI score ≤ 150.
Measured: 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.
Number of Participants with Clinical response as per CDAI (100 points)
Defined as reduction of the CDAI of at least 100 points or achieving a CDAI score ≤ 150.
Measured: 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.
Number of Participants with Clinical response as per CDAI (70 points)
Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
Measured: 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.
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.
Change of the inflammatory marker CRP.
Measured: 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 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.
Change of the inflammatory marker ESR.
Measured: 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 in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.
Change of the inflammatory marker fecal calprotectin.
Measured: 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.
Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score
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.
Measured: 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.
Patient global assessment
"Do you believe you are in remission from your CD symptoms?" (Yes/No). No scale.
Measured: 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.
Effect of IRCD on endoscopic outcomes
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.
Measured: 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.
Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)
Changes in SIBDQ. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start18 Dec 2019
- Primary completion12 Mar 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha Ranjit Sinha, Stanford University
- Investigators
- Sidhartha R Sinha, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147585
- Sponsor's protocol ID
- IRB 53161
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2019
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kulkarni C, Fardeen T, Gubatan J, Ye J, Jarr K, Dickson E, Jang H, Temby M, Patel A, Jiang Y, Singh G, Keyashian K, Streett S, Ho E, Barber G, Singh S, Limsui D, Anaizi N, Becker L, Spencer SP, Mehrish D, Perelman D, Longo VD, Charu V, Ashouri JF, Davis MM, Habtezion A, Sonnenburg JL, Gardner C, Sinha SR. A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial. Nat Med. 2026 Mar;32(3):1023-1033. doi: 10.1038/s41591-025-04173-w. Epub 2026 Jan 13.
PubMed 41530382
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
- ClinicalTrials.gov ID
- NCT04147585
- Acronym / sponsor ID
- IRB 53161
- Keywords
- IBD, Crohn's disease, Diet, Fasting, Intermittent Reduced Calorie Diet, CD, intermittent fasting, FMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Intermittent Reduced Calorie Diet (IRCD)Three cycles of a 5-day Intermittent Reduced Calorie Diet |
| Control Arm | No intervention | –Regular Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate Crohn's disease (CDAI score 151-450)
- Between the ages of 18-70 (inclusive)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Reduced Calorie Diet (IRCD)Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months. | Other | Intervention Arm |
Primary outcome
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.
10 secondary outcomes
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.
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.
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.
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 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 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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 41530382Kulkarni C, Fardeen T, Gubatan J, Ye J, Jarr K, Dickson E, Jang H, Temby M, Patel A, Jiang Y, Singh G, Keyashian K, Streett S, Ho E, Barber G, Singh S, Limsui D, Anaizi N, Becker L, Spencer SP, Mehrish D, Perelman D, Longo VD, Charu V, Ashouri JF, Davis MM, Habtezion A, Sonnenburg JL, Gardner C, Sinha SR. A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial. Nat Med. 2026 Mar;32(3):1023-1033. doi: 10.1038/s41591-025-04173-w. Epub 2026 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidhartha R Sinha, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Reduced Calorie Diet (IRCD) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.