Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Zhaoping Li

Description

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.

Official Title

Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy

Details

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.

Keywords

Inflammatory Bowel Diseases, Crohn Disease, Crohn's Disease, IBD, Anti-inflammatory Diet, Anti-Inflammatory Agents, Regular diet, Anti-inflammatory whole food

Eligibility

You can join if…

Open to people ages 18-75

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

You CAN'T join if...

  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.

Location

  • UCLA Center for Human Nutrition, 1000 Veteran Ave. accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Zhaoping Li
    Zhaoping Li, M.D., Ph.D., holds the Lynda and Stewart Resnick Endowed Chair in Human Nutrition.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04431700
Study Type
Interventional
Participants
Expecting 116 study participants
Last Updated