Inflammatory Bowel Diseases, Crohn Disease
Conditions
Keywords
Crohn's Disease, IBD, Anti-inflammatory Diet
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.
Interventions
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.
OTHERRegular diet
Focus on food journal and recording all food intake.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease | 8 weeks | The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission. |
Countries
United States
Outcome results
None listed