Crohn DiseaseNCT04239248
"Tasty&Healthy" Dietary Approach for Crohn's Disease
A study testing Tasty&Healthy intervention group and EEN intervention group in people with Crohn Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Despite the advent of multiple novel medications, many patients with Crohn's disease (CD) fail to achieve mucosal healing (MH). Exclusive enteral nutrition (EEN) has been shown to induce clinical remission accompanied by MH in many of CD patients. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Tasty&Healthy intervention group and EEN intervention group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2020to 1 Jul 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACTIVE-RCT-I
- Children and young adults aged 6-24 years with established diagnosis of CD by European crohn's and colitis organisation (ECCO) /The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.
- <1 years of disease duration since the time of CD diagnosis.
- Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
- Mild- moderate disease activity (wPCDAI 20-57.5 or CDAI 200-45) or milder disease (wPCDAI 12.5-57.5 or CDAI 150-450) that according to the physician's discretion warrants an immediate change in treatment (and thus cannot be included in the MH-RCT-II that has a non-treatment arm).
- Currently receiving no drug treatment or on maintenance treatment with immunomodulators (at stable dose for at least 16 weeks) or 5-aminosalicylic acid (5ASA)/sulfasalazine (at stable dose for at least 8 weeks). No current or prior treatment with biologics is allowed (i.e. biologic-naïve).
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- MH-RCT-II
- Children and young adults aged 6-40 years with established diagnosis of CD by ECCO/ESPGHAN criteria.
- <1 years of disease duration since the time of CD diagnosis, or <3 years of disease duration since the time of CD diagnosis for patients without evidence of significant bowel wall thickening (≤4 mm) without any damage as much as known.
- Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
- MINI ≥8 points.
- Clinical remission or at most minimal symptoms (wPCDAI<20/ CDAI<200) that according to the physician's discretion do not warrant immediate medical treatment.
- Receiving no treatment or on maintenance treatment with immunomodulators and/or first biologic (both at stable dose and interval for at least 16 weeks), and/or 5ASA/sulfasalazine (at stable dose for at least 8 weeks).
- Second line biologics are allowed for patients without evidence of significant bowel wall thickening (≤4 mm) without bowel damage as much as known.
Who cannot join
- Fibrostenotic or penetrating phenotype.
- Fistulizing perianal disease which is not in complete remission.
- "Ulcerative colitis (UC)-like" isolated Crohn's colitis.
- Prior failure of exclusive enteral nutrition or any other dietary intervention, for any reason.
- The use of steroids or budesonide in the recent month, or antibiotics prescribed to treat the CD in the previous two weeks.
- Any formula feed during the last month.
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- Prior intestinal resection.
- Pregnancy.
- Celiac disease.
- For ACTIVE-RCT-I: any prior or concurrent biologic therapy; for MH-RCT-II: any prior or concurrent biologic therapy other than second line biologic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Tasty&Healthy" is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease
Despite the advent of multiple novel medications, many patients with Crohn's disease (CD) fail to achieve mucosal healing (MH). Exclusive enteral nutrition (EEN) has been shown to induce clinical remission accompanied by MH in many of CD patients. The aim of this proposal is to explore the effectiveness of the "Tasty\&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults. This approach is based on the previously published charity cook-book "Tasty\&Healthy" and might be more feasible than currently available nutritional treatments in CD. It does not offer a rigid diet with specific nutrients and does not require concurrent use of a formula feed.
The investigators hypothesize that a flexible dietary intervention of excluding processed and pro-inflammatory ingredients will improve the rate of clinical remission and MH without the need for liquid formula or structured rigid diet which are more difficult to adhere to. The investigators also hypothesize that home kits of Fecal calprotectin (FC), can personalize the diet thereby increasing feasibility for maintenance therapy in some patients.
Read the detailed description
The investigators plan to conduct a set of three studies: Two randomized controlled trials (RCT) both including the Tasty\&Healthy dietary intervention for 8 weeks in CD patients aged 6-24 years vs. 1) EEN in mild-moderate CD, and the other RCT in CD patients aged 6-40 years vs. 2) a control group continuing their habitual diet in those with mucosal inflammation despite stable medical treatment, but who are in clinical remission or have only minimal symptoms not requiring immediate treatment.
As a third study, responders from both trials will be offered to participate in an open label extension personalized-diet study of further 16 weeks (total 24 weeks), in which gluten and dairy will be gradually re-introduced based on repeated monthly home assays of FC while otherwise following the Tasty\&Healthy dietary intervention in a treat-to-target management approach.
Patients will be evaluated at baseline, week 4 and week 8 with additional weekly phone visits to ensure adherence with the diets and address questions.
The extension study will include two clinic visits at weeks 16 and 24 and a monthly call to ensure adherence.
The investigators hope to establish a dietary-approach which is simpler to implement than current nutritional alternatives. It will enable high flexibility in the allowed foods and does not require liquid formula. In turn, this could position Tasty\&Healthy, not merely for inducing remission, but also as a feasible maintenance strategy in selected patients.
- Conditions
- Crohn Disease
- Being tested
- Tasty&Healthy intervention group, EEN intervention group
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasty&Healthy intervention groupDietary supplement
patients will receive dietary advice to exclude pro-inflammatory dietary components based on the book "Tasty\&Healthy".
EEN intervention groupDietary supplement
Oral exclusive feeding of formulated food (EEN), using Modulen formula only, for 8 weeks in amount based on the Daily Recommendations Intake. Those not tolerating oral EEN can receive EEN via a nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE-RCT-I Tasty&Healthy intervention group | Experimental | Patients with mild-moderately symptomatic disease, will follow the Tasty\&Healthy dietary approach. Receives: Dietary Supplement: Tasty&Healthy intervention group |
| ACTIVE-RCT-I Control group | Active comparator | Patients with mild-moderately symptomatic disease, will receive EEN with Modulen formula only. Receives: Dietary Supplement: EEN intervention group |
| MH-RCT-II Tasty&Healthy intervention group | Experimental | Patients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will follow the Tasty\&Healthy dietary approach. Receives: Dietary Supplement: Tasty&Healthy intervention group |
| MH-RCT-II Control group | No intervention | Patients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will continue their habitual diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACTIVE-RCT-I: patient's tolerance to the diet by week 8.
Percent of patients tolerating the diet. Tolerance is defined as the absence of all of the three following items:
- Intolerance: cessation of dietary therapy because of patient's refusal to continue diet (based on reporting and the 24 hour recall);
- Poor adherence based on the modified Medication Adherence Report Scale (MARS) questionnaire; The modified MARS questionnaire rates How closely patients adhere to the diet. This is a self-report measure of adherence. It can be used to determine patients' willingness and ability to comply with the diet daily. A score of 1-5 indicates that the patient is not adherent; a score of 6-9 indicates that the patient is adherent.
- Poor adherence based on direct questioning (any answer other than "adheres to diet very often/always" will be considered poor compliant).
Measured: 8 weeks
MH-RCT-II: Rate of mucosal healing (MH).
Percent of patients achieving MH defined by the proportion of patients with FC response as defined by reduction of at least 50% of FC levels from baseline; this has been added to the initial primary endpoint (i.e. MINI<8 points) after enrolling five patients given new data that the MINI is less accurate in adults.
Measured: 8 weeks
Secondary outcomes (3)
Percent of patients achieving MH rate at Week 8 assessed with panenteric capsule endoscopy (i.e. Crohn's capsule) at the end of both trials as the major secondary outcome.
Rate of MH defined by a central reading panel which will include leading irritable bowel disease (IBD) medical experts. This panel will determine the mucosal inflammation rate at week 8.
Measured: 8 weeks
Percent of patients achieving clinical remission rate
Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) by<12.5 points or Crohn's Disease Activity Index (CDAI)<150
Measured: 8 weeks
Response rate defined as percent of patients achieving clinical remission and either reduction of FC levels.
Clinical remission: wPCDAI by<12.5 points or CDAI<150, and either reduction of at least 50% of FC levels from baseline or FC levels<150 µgr/gr.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239248
- Sponsor's protocol ID
- Tasty&Healthy
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plotkin L, Aharoni-Frutkoff Y, Pollak D, Azulay A, Shavit Z, Focht G, Livovsky J, Lev-Tzion R, Koslowsky B, Boneh RS, Weiss B, Slae M, Dotan I, Godny L, Kierkus J, Garwolinska M, Broide E, Moshe G, Griffiths AM, Tersigni C, Naftali T, Abramas L, D'arcangelo G, Yerushalmy-Feler A, Schwerd T, Crowley E, Wine E, Yassour M, Reifen R, Turner D. Tasty&Healthy Whole-Food Diet in Asymptomatic Children and Young Adults With Biologically Active Crohn's Disease: The TASTI-E Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun 17:S1542-3565(26)00433-7. doi: 10.1016/j.cgh.2026.05.029. Online ahead of print.
PubMed 42309429Aharoni-Frutkoff Y, Plotkin L, Pollak D, Livovsky J, Focht G, Lev-Tzion R, Ledder O, Assa A, Yogev D, Orlanski-Meyer E, Broide E, Kierkus J, Kang B, Weiss B, Aloi M, Schwerd T, Shouval DS, Bramuzzo M, Griffiths AM, Yassour M, Turner D. Whole Food Diet Induces Remission in Children and Young Adults With Mild to Moderate Crohn's Disease and Is More Tolerable Than Exclusive Enteral Nutrition: A Randomized Controlled Trial. Gastroenterology. 2025 Dec;169(7):1462-1474.e2. doi: 10.1053/j.gastro.2025.06.011. Epub 2025 Jun 17.
PubMed 40553742
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Tasty&Healthy" is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04239248
- Acronym / sponsor ID
- Tasty&Healthy
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 27 Jan 2020 (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.
Despite the advent of multiple novel medications, many patients with Crohn's disease (CD) fail to achieve mucosal healing (MH). Exclusive enteral nutrition (EEN) has been shown to induce clinical remission accompanied by MH in many of CD patients. The aim of this proposal is to explore the effectiveness of the "Tasty\&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults. This approach is based on the previously published charity cook-book "Tasty\&Healthy" and might be more feasible than currently available nutritional treatments in CD. It does not offer a rigid diet with specific nutrients and does not require concurrent use of a formula feed.
The investigators hypothesize that a flexible dietary intervention of excluding processed and pro-inflammatory ingredients will improve the rate of clinical remission and MH without the need for liquid formula or structured rigid diet which are more difficult to adhere to. The investigators also hypothesize that home kits of Fecal calprotectin (FC), can personalize the diet thereby increasing feasibility for maintenance therapy in some patients.
Detailed description
The investigators plan to conduct a set of three studies: Two randomized controlled trials (RCT) both including the Tasty\&Healthy dietary intervention for 8 weeks in CD patients aged 6-24 years vs. 1) EEN in mild-moderate CD, and the other RCT in CD patients aged 6-40 years vs. 2) a control group continuing their habitual diet in those with mucosal inflammation despite stable medical treatment, but who are in clinical remission or have only minimal symptoms not requiring immediate treatment.
As a third study, responders from both trials will be offered to participate in an open label extension personalized-diet study of further 16 weeks (total 24 weeks), in which gluten and dairy will be gradually re-introduced based on repeated monthly home assays of FC while otherwise following the Tasty\&Healthy dietary intervention in a treat-to-target management approach.
Patients will be evaluated at baseline, week 4 and week 8 with additional weekly phone visits to ensure adherence with the diets and address questions.
The extension study will include two clinic visits at weeks 16 and 24 and a monthly call to ensure adherence.
The investigators hope to establish a dietary-approach which is simpler to implement than current nutritional alternatives. It will enable high flexibility in the allowed foods and does not require liquid formula. In turn, this could position Tasty\&Healthy, not merely for inducing remission, but also as a feasible maintenance strategy in selected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACTIVE-RCT-I Tasty&Healthy intervention group | Experimental | Dietary Supplement: Tasty&Healthy intervention groupPatients with mild-moderately symptomatic disease, will follow the Tasty\&Healthy dietary approach. |
| ACTIVE-RCT-I Control group | Active comparator | Dietary Supplement: EEN intervention groupPatients with mild-moderately symptomatic disease, will receive EEN with Modulen formula only. |
| MH-RCT-II Tasty&Healthy intervention group | Experimental | Dietary Supplement: Tasty&Healthy intervention groupPatients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will follow the Tasty\&Healthy dietary approach. |
| MH-RCT-II Control group | No intervention | –Patients with laboratory evidence of mucosal inflammation but who are asymptomatic or have only minimal symptoms not requiring immediate treatment modification, will continue their habitual diet. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- ACTIVE-RCT-I
- Children and young adults aged 6-24 years with established diagnosis of CD by European crohn's and colitis organisation (ECCO) /The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.
- <1 years of disease duration since the time of CD diagnosis.
- Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
- Mild- moderate disease activity (wPCDAI 20-57.5 or CDAI 200-45) or milder disease (wPCDAI 12.5-57.5 or CDAI 150-450) that according to the physician's discretion warrants an immediate change in treatment (and thus cannot be included in the MH-RCT-II that has a non-treatment arm).
Key exclusion criteria (10 listed)
- Fibrostenotic or penetrating phenotype.
- Fistulizing perianal disease which is not in complete remission.
- "Ulcerative colitis (UC)-like" isolated Crohn's colitis.
- Prior failure of exclusive enteral nutrition or any other dietary intervention, for any reason.
- The use of steroids or budesonide in the recent month, or antibiotics prescribed to treat the CD in the previous two weeks.
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 |
|---|---|---|
| Tasty&Healthy intervention grouppatients will receive dietary advice to exclude pro-inflammatory dietary components based on the book "Tasty\&Healthy". | Dietary supplement | ACTIVE-RCT-I Tasty&Healthy intervention group, MH-RCT-II Tasty&Healthy intervention group |
| EEN intervention groupOral exclusive feeding of formulated food (EEN), using Modulen formula only, for 8 weeks in amount based on the Daily Recommendations Intake. Those not tolerating oral EEN can receive EEN via a nasogastric tube. | Dietary supplement | ACTIVE-RCT-I Control group |
Primary outcome
ACTIVE-RCT-I: patient's tolerance to the diet by week 8.
Time frame: 8 weeks
Percent of patients tolerating the diet. Tolerance is defined as the absence of all of the three following items: 1. Intolerance: cessation of dietary therapy because of patient's refusal to continue diet (based on reporting and the 24 hour recall); 2. Poor adherence based on the modified Medication Adherence Report Scale (MARS) questionnaire; The modified MARS questionnaire rates How closely patients adhere to the diet. This is a self-report measure of adherence. It can be used to determine patients' willingness and ability to comply with the diet daily. A score of 1-5 indicates that the patient is not adherent; a score of 6-9 indicates that the patient is adherent. 3. Poor adherence based on direct questioning (any answer other than "adheres to diet very often/always" will be considered poor compliant).
MH-RCT-II: Rate of mucosal healing (MH).
Time frame: 8 weeks
Percent of patients achieving MH defined by the proportion of patients with FC response as defined by reduction of at least 50% of FC levels from baseline; this has been added to the initial primary endpoint (i.e. MINI<8 points) after enrolling five patients given new data that the MINI is less accurate in adults.
3 secondary outcomes
Percent of patients achieving MH rate at Week 8 assessed with panenteric capsule endoscopy (i.e. Crohn's capsule) at the end of both trials as the major secondary outcome.
Time frame: 8 weeks
Percent of patients achieving clinical remission rate
Time frame: 8 weeks
Response rate defined as percent of patients achieving clinical remission and either reduction of FC levels.
Time frame: 8 weeks
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 27 Apr 2025.
- Derived from this study: PubMed 42309429Plotkin L, Aharoni-Frutkoff Y, Pollak D, Azulay A, Shavit Z, Focht G, Livovsky J, Lev-Tzion R, Koslowsky B, Boneh RS, Weiss B, Slae M, Dotan I, Godny L, Kierkus J, Garwolinska M, Broide E, Moshe G, Griffiths AM, Tersigni C, Naftali T, Abramas L, D'arcangelo G, Yerushalmy-Feler A, Schwerd T, Crowley E, Wine E, Yassour M, Reifen R, Turner D. Tasty&Healthy Whole-Food Diet in Asymptomatic Children and Young Adults With Biologically Active Crohn's Disease: The TASTI-E Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun 17:S1542-3565(26)00433-7. doi: 10.1016/j.cgh.2026.05.029. Online ahead of print.
- Derived from this study: PubMed 40553742Aharoni-Frutkoff Y, Plotkin L, Pollak D, Livovsky J, Focht G, Lev-Tzion R, Ledder O, Assa A, Yogev D, Orlanski-Meyer E, Broide E, Kierkus J, Kang B, Weiss B, Aloi M, Schwerd T, Shouval DS, Bramuzzo M, Griffiths AM, Yassour M, Turner D. Whole Food Diet Induces Remission in Children and Young Adults With Mild to Moderate Crohn's Disease and Is More Tolerable Than Exclusive Enteral Nutrition: A Randomized Controlled Trial. Gastroenterology. 2025 Dec;169(7):1462-1474.e2. doi: 10.1053/j.gastro.2025.06.011. Epub 2025 Jun 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tasty&Healthy intervention group and EEN intervention group in people with Crohn Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
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 14 inclusion and 10 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 27 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 Israel. 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?
ACTIVE-RCT-I: patient's tolerance to the diet by week 8. (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04239248, which also lists 2 linked publications.
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 27 Apr 2025.