Diet Intervention for Crohn's Disease Patient

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: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Behavioral: Diet Counseling; Other: CD LFD; Behavioral: Dyadic Psychological Support (DPS)

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith Pignac Kobinger, m; Phone Number: 305-243-6217; Email: jpignac@med.miami.edu
• Study Contact Backup: Name: Maria A Quintero, MPH; Phone Number: 305-243-4717; Email: mquintero2@med.miami.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in fat intake	Change in daily fat intake calculated through patient reported diet diary app Nutrihand.	Baseline, 8 weeks
Rate of adherence to fat intake	Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).	Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).	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)	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).	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).	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).	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).	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).	Change in the expression of SAA evaluated in pg/mL.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Principal Investigator: Maria T Abreu, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Diet; IBD; CD; Psychological support; Family member; Inflammatory bowel disease (IBD); Low fat, high fiber; Dyadic
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID 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