Clinical trial NCT04431700: Study of Dietary Composition in Crohn's Disease
Official title: Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Keywords: Crohn's Disease
IBD
Anti-inflammatory Diet
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
Primary purpose: PREVENTION

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.

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:

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.

Primary outcomes:
measure: Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, 1000 Veteran Ave.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: