Diet Intervention for Crohn's Disease Patient

February 28, 2024 updated by: Maria Abreu, University of Miami

A Holistic Diet Intervention for People With Crohn's Disease

The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Crohn's disease:

  • Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
  • Documented diagnosed of Crohn's Disease
  • sCDAI less than 400
  • Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
  • Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks
  • On steroids can be on no more than prednisone 20 mg daily or budesonide 9 mg daily at the screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/wk and budesonide by no more than 3 mg/wk.
  • No antibiotic use or probiotic use within 2 weeks prior to screening

Exclusion Criteria for Crohn's disease:

Patients with Ulcerative Colitis and Celiac Disease

  • Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
  • Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy
  • Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
  • Need for prednisone > 20 mg daily or budesonide > 9 mg daily at the time of screening. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period except as premedication for anti-TNFs
  • Use of Total Parenteral Nutrition at the time of screening and during the study period.
  • Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks; Hemoglobin <8.0g/dl, Albumin <2.8g/dl.
  • Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure
  • Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
  • The need for antibiotic use during the study period
  • Known allergy to tree nuts or peanuts
  • Pregnant women

Inclusion and Exclusion Criteria for Family-like Member

Inclusion:

  • Male or Female ≥18 and ≤70 years old
  • Live in the same household and be involved in the patients' daily diet
  • No antibiotic use or probiotic use within 2 weeks prior to screening

Exclusion Criteria

  • Patients with Ulcerative Colitis and Celiac Disease
  • Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
  • Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedures. Patients with short life expectancy
  • Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
  • Use of Total Parenteral Nutrition at the time of screening and during the study period.
  • Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
  • The need for antibiotic use during the study period
  • Known allergy to tree nuts or peanuts
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Crohn's Disease (CD) Control Group
Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.
Behavioral: Diet Counseling
Standard of care diet counseling provided at clinic visit 1.
Experimental: Experimental CD Low Fat Diet (LFD) Group
Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.
Other: CD LFD
Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day.
Experimental: Experimental CD LFD + DPS Group
Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS).
Other: CD LFD
Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day.
Behavioral: Dyadic Psychological Support (DPS)
The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fat intake
Time Frame: Baseline, 8 weeks
Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
Baseline, 8 weeks
Rate of adherence to fat intake
Time Frame: Week 36
Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).
Time Frame: Baseline, Week 8
PRO2 is the sum of the average daily stool frequency and abdominal pain. A weighted total PRO2 score of less than 75 is an indication of remission.
Baseline, Week 8
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
Time Frame: Baseline, Week 8
HBI is a 5-item questionnaire. An HBI score of <5 indicates remission, 5-7 indicates mild disease, 8-16 indicates moderate disease and >16 indicates severe disease.
Baseline, Week 8
Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).
Time Frame: Baseline, Week 8
sCDAI is the sum of the average daily stool frequency, general well-being and abdominal pain. A weighted total sCDAI score of less than 150 indicates remission, 150-219 indicates mild activity, 220-450 indicates moderate activity and > 450 indicates severe activity.
Baseline, Week 8
Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).
Time Frame: Baseline, Week 8
sIBDQ is a 10-item shortened version of the original IBDQ assessing QOL with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Baseline, Week 8
Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).
Time Frame: Baseline, Week 8
The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. A score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).
Baseline, Week 8
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).
Time Frame: Baseline, Week 8
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L.
Baseline, Week 8
Change in the expression of Serum Amyloid A (SAA).
Time Frame: Baseline, Week 8
Change in the expression of SAA evaluated in pg/mL.
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria T Abreu, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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