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 : November 11, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Crohn Disease||Other: Anti-inflammatory diet Other: Regular diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|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)|
|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|
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.
- 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|
- Age of 18 to 75 years old
- History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
History or current diagnosis of any of the following:
- Stroke or Arrhythmia
- 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
- 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.
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
|Contact: Gail Thames||310-825-0453||Gthames@mednet.ucla.edu|
|Contact: Dina Ben-Nissan||310-206-2582||Dbennissan@mednet.ucla.edu|
|United States, California|
|UCLA Center for Human Nutrition, 1000 Veteran Ave.||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Gail Thames 310-825-0453 email@example.com|
|Contact: Dina Ben-Nissan 310-206-2582 firstname.lastname@example.org|
|Principal Investigator: Zhaoping Li|
|Principal Investigator:||Zhaoping Li, MD, PhD||University of California, Los Angeles|
|Responsible Party:||Zhaoping Li, Principal Investigator, University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||June 16, 2020 Key Record Dates|
|Last Update Posted:||November 11, 2021|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Inflammatory Bowel Diseases
Digestive System Diseases