Crohn DiseaseDAINNCT05627128
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
A study testing DAIN in people with Crohn Disease, run by University of Massachusetts, Worcester at 2 sites in 2 countries.
Trial summary
The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- DAIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Sep 2022to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 65 years old
- Confirmed CD diagnosis with sCDAI <450 (includes values ranging from remission, mild to moderate activity)
- Moderate to severe impaired QoL (sIBDQ<60)
- Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week)
- Willingness and capacity to significantly change diet (arm 1)
- Willing and able to comply with specimen collection and other study procedures, and to complete the study
Who cannot join
- Ostomy
- Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening
- Use of prescribed probiotics within 4 weeks of screening
- > 20mg prednisone or equivalent
- Recent C. difficile colitis
- Pregnancy
- Presence of symptomatic or significant structure or history of obstruction in the past 6 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Massachusetts Chan MedicaL School
Worcester, Massachusetts, 01605
About this study
Official title: Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.
Read the detailed description
Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients.
Participants will be randomized 1:1 ratio into two arms:
- Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10)
- Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.
Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico.
The primary outcome is Improvement of health-related quality of life. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.
- Conditions
- Crohn Disease
- Being tested
- DAIN
- Keywords
- diet, inflammation, microbiome
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAINOther
Participants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Crohn's disease patients + DAIN | Experimental | Participants will have 10 weeks of DAIN intervention (From week 1 to week 10) Receives: Other: DAIN |
| Arm 2: Crohn's disease patients no intervention | No intervention | Participants will continue consuming their usual diet, with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of health-related quality of life
Improvement of health-related quality of life (increase of the short Inflammatory Bowel Disease Questionnaire score (SIBDQ)). The SIBDQ scores range between 10 and 70 points. A slightly impaired quality of life is indicated by scores from 60 to 70 points, moderately impaired quality of life from 45 to 60 points, and severely impaired quality of life from 10 to 45 points.
Measured: Week 0, 6, 10, 14
Secondary outcomes (4)
Change of Inflammation
Changes in inflammation will be determined by levels of calprotectin in stools and C-reactive protein (CRP) in the blood. Both stool and blood will be collected at each time point. Decreased levels of fecal calprotectin and CRP indicate a decrease in inflammation and vice versa.
Measured: Week 0, 6, 10, 14
Gut Microbiome changes
Gut microbiome changes related to the dietary intervention will be assessed by metagenomic shotgun sequencing of stool samples collected at each time point.
Measured: Week 0, 6, 10, 14
Dietary compliance
DAIN Dietary compliance will be evaluated by calculating the Healthy Eating Index (HEI) score from the assessment tools: 24-Hour Dietary Recalls (24HDRs) and Food Frequency Questionnaires, surveyed at each time point. The HEI is composed of 13 diet components: total fruits, whole fruits, total vegetables, greens and beans, dairy, total protein foods, seafood and plant proteins, fatty acids, refined grains, whole grains, sodium, added sugars, and saturated fats. A minimum number of servings per component have been established, and the scoring of the HEI components is based on these established values. The total maximum score is equal to 100. Higher values represent closer compliance with DAIN.
Measured: Week 0, 6, 10, 14
Clinical response and remission
Clinical response and clinical remission will be assessed by reduction of the Short Crohn's Disease Activity Index or SCDAI. Scores range from 0 to 600 with different. A score less than 150 indicates remission, a score between 150-219 indicates mild activity, a score from 220 and 450 indicates moderate activity, and a score greater than 450 indicates severe activity.
Measured: Week 0, 6, 10, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start6 Sep 2022
- Primary completion31 May 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Model description
- Randomized intervention trial in adults with Crohn's disease.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Ana Maldonado-Contreras, University of Massachusetts, Worcester
- Investigators
- Ana L Maldonado-Contreras, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627128
- Sponsor's protocol ID
- 1250122
- Other IDs
- R-2102-05006
- Acronym
- DAIN
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All sequence data generated in this trial are understood to represent community resources and will be submitted to the appropriate public database. Specifically, data will be submitted to the NCBI (https://www.ncbi.nlm.nih.gov/), lncrnadb (http://www.lncrnadb.org/), and NONCODE (http://www.noncode.org/) databases as soon as sequencing data becomes available but not later than 2 years. Sequence data will also include information on quality values for each sequence as well as required fields for metagenomic data. The study will be in compliance with the NIH Genomic Data Sharing (GDS). Materials generated under the project will be disseminated in accordance with University/ Participating institutional and NIH policies.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
- ClinicalTrials.gov ID
- NCT05627128
- Acronym / sponsor ID
- DAIN / 1250122
- Conditions
- Crohn Disease
- Keywords
- diet, inflammation, microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Puerto Rico, The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 Nov 2022 (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 goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.
Detailed description
Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients.
Participants will be randomized 1:1 ratio into two arms:
- Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10)
- Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.
Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico.
The primary outcome is Improvement of health-related quality of life. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized intervention trial in adults with Crohn's disease.
| Arm | Type | Receives |
|---|---|---|
| Arm1: Crohn's disease patients + DAIN | Experimental | Other: DAINParticipants will have 10 weeks of DAIN intervention (From week 1 to week 10) |
| Arm 2: Crohn's disease patients no intervention | No intervention | –Participants will continue consuming their usual diet, with no intervention |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 to 65 years old
- Confirmed CD diagnosis with sCDAI <450 (includes values ranging from remission, mild to moderate activity)
- Moderate to severe impaired QoL (sIBDQ<60)
- Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week)
- Willingness and capacity to significantly change diet (arm 1)
Key exclusion criteria (7 listed)
- Ostomy
- Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening
- Use of prescribed probiotics within 4 weeks of screening
- > 20mg prednisone or equivalent
- Recent C. difficile colitis
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 |
|---|---|---|
| DAINParticipants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef. | Other | Arm1: Crohn's disease patients + DAIN |
Primary outcome
Improvement of health-related quality of life
Time frame: Week 0, 6, 10, 14
Improvement of health-related quality of life (increase of the short Inflammatory Bowel Disease Questionnaire score (SIBDQ)). The SIBDQ scores range between 10 and 70 points. A slightly impaired quality of life is indicated by scores from 60 to 70 points, moderately impaired quality of life from 45 to 60 points, and severely impaired quality of life from 10 to 45 points.
4 secondary outcomes
Change of Inflammation
Time frame: Week 0, 6, 10, 14
Gut Microbiome changes
Time frame: Week 0, 6, 10, 14
Dietary compliance
Time frame: Week 0, 6, 10, 14
Clinical response and remission
Time frame: Week 0, 6, 10, 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. All sequence data generated in this trial are understood to represent community resources and will be submitted to the appropriate public database. Specifically, data will be submitted to the NCBI (https://www.ncbi.nlm.nih.gov/), lncrnadb (http://www.lncrnadb.org/), and NONCODE (http://www.noncode.org/) databases as soon as sequencing data becomes available but not later than 2 years. Sequence data will also include information on quality values for each sequence as well as required fields for metagenomic data. The study will be in compliance with the NIH Genomic Data Sharing (GDS). Materials generated under the project will be disseminated in accordance with University/ Participating institutional and NIH policies.
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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.
Ana L Maldonado-Contreras, PhD principal investigator
University of Massachusetts, Worcester
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAIN in people with Crohn Disease, run by University of Massachusetts, Worcester at 2 sites in 2 countries.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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?
This study is still under way. Results are not available in the source record yet.
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?
Improvement of health-related quality of life (time frame: Week 0, 6, 10, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.