Diet Intervention for Crohn's Disease Patient

NCT04213729 | Completed

• 1 other identifier: 20190548
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Keywords

Inflammatory bowel disease (IBD); Diet; CD; IBD; Psychological support; Family member; Low fat, high fiber; Dyadic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).

  Baseline, Week 8

• Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)

  Baseline, Week 8

• Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).

  Baseline, Week 8

• Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).

  Baseline, Week 8

• Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).

  Baseline, Week 8

Study Arms (3)

Crohn's Disease (CD) Control Group

ACTIVE COMPARATOR

Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.

Behavioral: Diet Counseling

Experimental CD Low Fat Diet (LFD) Group

EXPERIMENTAL

Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.

Other: CD LFD

Experimental CD LFD + DPS Group

EXPERIMENTAL

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; Behavioral: Dyadic Psychological Support (DPS)

Interventions

Diet Counseling BEHAVIORAL

Standard of care diet counseling provided at clinic visit 1.

Crohn's Disease (CD) Control Group

CD LFD OTHER

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 CD LFD + DPS Group; Experimental CD Low Fat Diet (LFD) Group

Dyadic Psychological Support (DPS) BEHAVIORAL

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.

Experimental CD LFD + DPS Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Miami: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maria T Abreu, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 30, 2019
• Study Start: November 26, 2019
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)