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

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ClinicalTrials.gov Identifier: NCT04431700
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Other: Anti-inflammatory diet Other: Regular diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Anti-inflammatory whole food
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.
Other: Anti-inflammatory diet
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.

Active Comparator: Regular Diet
Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.
Other: Regular diet
Focus on food journal and recording all food intake.




Primary Outcome Measures :
  1. Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease [ Time Frame: 8 weeks ]
    The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431700


Contacts
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Contact: Gail Thames 310-825-0453 Gthames@mednet.ucla.edu
Contact: Dina Ben-Nissan 310-206-2582 Dbennissan@mednet.ucla.edu

Locations
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United States, California
UCLA Center for Human Nutrition, 1000 Veteran Ave. Recruiting
Los Angeles, California, United States, 90095
Contact: Gail Thames    310-825-0453    gthames@mednet.ucla.edu   
Contact: Dina Ben-Nissan    310-206-2582    dbennissan@mednet.ucla.edu   
Principal Investigator: Zhaoping Li         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li, MD, PhD University of California, Los Angeles
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Responsible Party: Zhaoping Li, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04431700    
Other Study ID Numbers: 20-001120
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
Crohn's Disease
IBD
Anti-inflammatory Diet
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents