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Study of Dietary Composition in Crohn's Disease (CD)

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-inflammatory diet
Regular diet
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring Crohn's Disease, IBD, Anti-inflammatory Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 18 to 75 years old
  • History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof

Exclusion Criteria:

  1. History or current diagnosis of any of the following:

    • Stroke or Arrhythmia
    • Seizures
    • Liver Disease
    • Untreated hypertension (High Blood Pressure)
    • Active malignancy
    • Bleeding disorders
    • Heart Disease
    • Lung disease
    • Previous Heart surgery
    • Previous Gastrointestinal Surgery
    • Kidney Disease
    • Chronic Diarrhea
    • End enterostomy
    • Bulimia
    • Anorexia
    • Laxative Abuse
    • Endocrine Disorder
    • Current history of smoking tobacco
    • Urgent need for abdominal sugery
    • Severe Malnutrition
    • Active alcohol or non-cannabinoid substance abuse
  2. Recent hospitalization within the last 30 days
  3. Currently pregnant of lactating.
  4. Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.
  5. Concerns for non-compliance
  6. If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.

Sites / Locations

  • UCLA Center for Human Nutrition, 1000 Veteran Ave.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anti-inflammatory whole food

Regular Diet

Arm Description

Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.

Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.

Outcomes

Primary Outcome Measures

Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2020
Last Updated
May 4, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04431700
Brief Title
Study of Dietary Composition in Crohn's Disease
Acronym
CD
Official Title
Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

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

5. Study Description

Brief Summary
Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.
Detailed Description
A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease
Keywords
Crohn's Disease, IBD, Anti-inflammatory Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-inflammatory whole food
Arm Type
Experimental
Arm Description
Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.
Arm Title
Regular Diet
Arm Type
Active Comparator
Arm Description
Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.
Intervention Type
Other
Intervention Name(s)
Anti-inflammatory diet
Intervention Description
Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.
Intervention Type
Other
Intervention Name(s)
Regular diet
Intervention Description
Focus on food journal and recording all food intake.
Primary Outcome Measure Information:
Title
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
Description
The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 to 75 years old History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof Exclusion Criteria: History or current diagnosis of any of the following: Stroke or Arrhythmia Seizures Liver Disease Untreated hypertension (High Blood Pressure) Active malignancy Bleeding disorders Heart Disease Lung disease Previous Heart surgery Previous Gastrointestinal Surgery Kidney Disease Chronic Diarrhea End enterostomy Bulimia Anorexia Laxative Abuse Endocrine Disorder Current history of smoking tobacco Urgent need for abdominal sugery Severe Malnutrition Active alcohol or non-cannabinoid substance abuse Recent hospitalization within the last 30 days Currently pregnant of lactating. Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study. Concerns for non-compliance If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gail Thames
Phone
310-825-0453
Email
Gthames@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Ben-Nissan
Phone
310-206-2582
Email
Dbennissan@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition, 1000 Veteran Ave.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail Thames
Phone
310-825-0453
Email
gthames@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Dina Ben-Nissan
Phone
310-206-2582
Email
dbennissan@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Zhaoping Li

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Dietary Composition in Crohn's Disease

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