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A Culturally Tailored Dietary Intervention to Treat Crohn's Disease (DAIN)

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DAIN
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring diet, inflammation, microbiome

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 21 to 65 years old Confirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450) Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (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

Sites / Locations

  • University of Massachusetts Chan MedicaL School
  • University of Puerto RicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm1: Crohn's disease patients + DAIN

Arm 2: Crohn's disease patients no intervention

Arm Description

Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)

Participants will continue consuming their usual diet, with no intervention

Outcomes

Primary Outcome Measures

Clinical response and remission
Clinical response and remission will be assessed by the Short Crohn's Disease Activity Index (sCDAI) surveyed at each time point. sCDAI scores range from 0 (no active disease) to 600 points (severe disease). An sCDAI reduction of 70 points will be considered clinical response and an sCDAI < 150 points will be considered remission.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 11, 2022
Last Updated
June 21, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
University of Puerto Rico, The Leona M. and Harry B. Helmsley Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05627128
Brief Title
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
Acronym
DAIN
Official Title
Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
University of Puerto Rico, The Leona M. and Harry B. Helmsley Charitable Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 clinical response and remission. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, and (iii) dietary compliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
diet, inflammation, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized intervention trial in adults with Crohn's disease.
Masking
InvestigatorOutcomes Assessor
Masking Description
All staff collecting data (e.g., dietary assessment) or assaying samples (e.g., fecal calprotectin, cytokines, sequencing) including the PI's, will be blinded to diet group assignments.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm1: Crohn's disease patients + DAIN
Arm Type
Experimental
Arm Description
Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)
Arm Title
Arm 2: Crohn's disease patients no intervention
Arm Type
No Intervention
Arm Description
Participants will continue consuming their usual diet, with no intervention
Intervention Type
Other
Intervention Name(s)
DAIN
Intervention Description
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 Outcome Measure Information:
Title
Clinical response and remission
Description
Clinical response and remission will be assessed by the Short Crohn's Disease Activity Index (sCDAI) surveyed at each time point. sCDAI scores range from 0 (no active disease) to 600 points (severe disease). An sCDAI reduction of 70 points will be considered clinical response and an sCDAI < 150 points will be considered remission.
Time Frame
Week 0, 6, 10, 14
Secondary Outcome Measure Information:
Title
Change of Inflammation
Description
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.
Time Frame
Week 0, 6, 10, 14
Title
Gut Microbiome changes
Description
Gut microbiome changes related to the dietary intervention will be assessed by metagenomic shotgun sequencing of stool samples collected at each time point.
Time Frame
Week 0, 6, 10, 14
Title
Dietary compliance
Description
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.
Time Frame
Week 0, 6, 10, 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21 to 65 years old Confirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450) Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana L Maldonado-Contreras, PhD
Phone
774-455-3796
Email
ana.maldonado@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mayra F Rojas Correa
Phone
508-856-5279
Email
mayra.rojascorrea@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana L Maldonado-Contreras, PhD
Organizational Affiliation
University of Massachusetts Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Chan MedicaL School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Torres, MD
Phone
787-754-0101
Ext
5444
Email
estheratorresmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Yoshimarie Mendez, MPH
Phone
787-754-0101
Ext
5444
Email
yoshimarie.mendez@upr.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. A portal will be created on the study website whereby anyone interested in collaborating or accessing to the data may submit a request form. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data, which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.

Learn more about this trial

A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

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