---
title: "A Culturally Tailored Dietary Intervention to Treat Crohn's Disease"
nct_id: NCT05627128
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: University of Massachusetts, Worcester
study_type: INTERVENTIONAL
primary_condition: Crohn Disease
countries: United States, Puerto Rico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05627128.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05627128"
ct_last_update_post_date: 2026-04-17
last_seen_at: "2026-05-12T06:31:28.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

**Official Title:** Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans

**NCT ID:** [NCT05627128](https://clinicaltrials.gov/study/NCT05627128)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** University of Massachusetts, Worcester
- **Collaborators:** University of Puerto Rico, The Leona M. and Harry B. Helmsley Charitable Trust
- **Conditions:** Crohn Disease
- **Start Date:** 2022-09-06
- **Completion Date:** 2026-11-30
- **CT.gov Last Update:** 2026-04-17

## Brief 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. 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
```

## Arms

- **Arm1: Crohn's disease patients + DAIN** (EXPERIMENTAL) — Participants 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

## Interventions

- **DAIN** (OTHER) — 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.

## Primary Outcomes

- **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.

## 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)_

## Locations (2)

- University of Massachusetts Chan MedicaL School, Worcester, Massachusetts, United States
- University of Puerto Rico, San Juan, Puerto Rico, Puerto Rico

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of massachusetts chan medical school|worcester|massachusetts|united states` — added _(2026-05-12)_
- `locations.university of puerto rico|san juan|puerto rico|puerto rico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05627128.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05627128*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*