Inflammatory Bowel DiseasesCDNCT04431700
Study of Dietary Composition in Crohn's Disease
A study testing Anti-inflammatory diet and Regular diet in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- Anti-inflammatory diet and Regular diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 to 75 years old
- History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
Who cannot join
- History or current diagnosis of any of the following:
- Stroke or Arrhythmia
- Seizures
- Liver Disease
- Untreated hypertension (High Blood Pressure)
- Active malignancy
Show all 27Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, 90095
About this study
Official title: Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Being tested
- Anti-inflammatory diet, Regular diet
- Keywords
- Crohn's Disease, IBD, Anti-inflammatory Diet
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory dietOther
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.
Regular dietOther
Focus on food journal and recording all food intake.
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory whole food | Experimental | 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. Receives: Other: Anti-inflammatory diet |
| Regular Diet | Active comparator | Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake. Receives: Other: Regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 Oct 2020
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Unable to complete enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431700
- Sponsor's protocol ID
- 20-001120
- Acronym
- CD
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limketkai BN, Yang J, Chau L, Noorian S, Li Z. Randomized controlled trial of a natural whole food diet versus habitual diet for Crohn's disease: Is diet quality the key? Clin Nutr ESPEN. 2025 Oct;69:580-589. doi: 10.1016/j.clnesp.2025.08.015. Epub 2025 Aug 14.
PubMed 40818622
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
- ClinicalTrials.gov ID
- NCT04431700
- Acronym / sponsor ID
- CD / 20-001120
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- Crohn's Disease, IBD, Anti-inflammatory Diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory whole food | Experimental | Other: Anti-inflammatory dietIncluded 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. |
| Regular Diet | Active comparator | Other: Regular dietPatients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 to 75 years old
- History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
Key exclusion criteria (27 listed)
- History or current diagnosis of any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-inflammatory dietAnti-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. | Other | Anti-inflammatory whole food |
| Regular dietFocus on food journal and recording all food intake. | Other | Regular Diet |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Unable to complete enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 40818622Limketkai BN, Yang J, Chau L, Noorian S, Li Z. Randomized controlled trial of a natural whole food diet versus habitual diet for Crohn's disease: Is diet quality the key? Clin Nutr ESPEN. 2025 Oct;69:580-589. doi: 10.1016/j.clnesp.2025.08.015. Epub 2025 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory diet and Regular diet in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to complete enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.