Ulcerative ColitisNCT06784323
Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
A study testing Catered diet, Diet guidance sessions and Dietary counseling in people with Ulcerative Colitis, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Catered diet, Diet guidance sessions and Dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented diagnosis with ulcerative colitis from medical records.
- Self-Identify as American
- Ages 16-75
- SCCAI between 3-9 (no greater than 12 bowel movements a day)
- Fecal calprotectin > 150mg/dl.
- On stable medications for their disease for the past 3 months
- Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)
- No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.
Who cannot join
- Diagnosis of Crohn's Disease (CD).
- Prior ileoanal anastomosis (J-pouch) or diversion
- No recent hospitalizations on the last 4 weeks
- No Clostridium difficile or enteric infections on the last 4 weeks
- No use of probiotics on the last 4 weeks
- Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
Show all 14Show fewer
- No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
- Pregnancy, breastfeeding or planning to become pregnant during study period
- Use of Total Parenteral Nutrition at the time of screening and during the study period
- Other significant or life-threatening co-morbidities
- The need for antibiotic use during the study period
- Adults unable to consent
- Ages less than 16 and > 75 years old
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Health System
Miami, Florida, 33136
Niurka Colina, CRC, 305 243-6405, nxc610@miami.edu
Michael Mijares, 305 243-6405, mmijares74@med.miami.edu
About this study
Official title: A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.
- Conditions
- Ulcerative Colitis
- Being tested
- Catered diet, Diet guidance sessions, Dietary counseling, Feedback sessions
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catered dietBehavioural
For a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods.
Diet guidance sessionsBehavioural
Participants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes.
Dietary counselingBehavioural
Participants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy.
Feedback sessionsBehavioural
Participants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability.
| Study group | Role | What they receive |
|---|---|---|
| Catered diet group | Experimental | Participants will be in this arm for up to 8 weeks. Receives: Behavioral: Catered diet; Behavioral: Diet guidance sessions; Behavioral: Dietary counseling; Behavioral: Feedback sessions |
| Diet guidance sessions group | Experimental | Participants will be in this arm for up to 8 weeks. Receives: Behavioral: Catered diet; Behavioral: Diet guidance sessions; Behavioral: Dietary counseling; Behavioral: Feedback sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)
Will be measured with SCCAI.
Measured: Up to 8 weeks
Secondary outcomes (1)
Fecal calprotectin
Change in fecal calprotectin.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Mar 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriana Mazorra Damas, University of Miami
- Investigators
- Oriana Damas, MD, MSCTI, Principal investigator, University of Miami Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784323
- Sponsor's protocol ID
- 20240857
- Other IDs
- 1R01DK140964-01
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06784323
- Acronym / sponsor ID
- 20240857
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 20 Jan 2025 (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.
The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catered diet group | Experimental | Behavioral: Catered diet, Behavioral: Diet guidance sessions, Behavioral: Dietary counseling, Behavioral: Feedback sessionsParticipants will be in this arm for up to 8 weeks. |
| Diet guidance sessions group | Experimental | Behavioral: Catered diet, Behavioral: Diet guidance sessions, Behavioral: Dietary counseling, Behavioral: Feedback sessionsParticipants will be in this arm for up to 8 weeks. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Documented diagnosis with ulcerative colitis from medical records.
- Self-Identify as American
- Ages 16-75
- SCCAI between 3-9 (no greater than 12 bowel movements a day)
- Fecal calprotectin > 150mg/dl.
Key exclusion criteria (14 listed)
- Diagnosis of Crohn's Disease (CD).
- Prior ileoanal anastomosis (J-pouch) or diversion
- No recent hospitalizations on the last 4 weeks
- No Clostridium difficile or enteric infections on the last 4 weeks
- No use of probiotics on the last 4 weeks
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 |
|---|---|---|
| Catered dietFor a period of 8 weeks the participant will receive catered food, the study team will provide the participants breakfast, lunch and dinner. Participants will receive catered food for 3 daily meals, and record daily food intake. Catered diet will be sent to participants' homes on a weekly basis. The diet will consist of primarily whole foods with few additives, with a focus on American staple foods. | Behavioural | Catered diet group, Diet guidance sessions group |
| Diet guidance sessionsParticipants will receive virtual weekly diet guidance with a dietitian regarding food safety preparation methods and cooking practices. Patients will receive weekly gift cards for grocery stipend. On average, initial counseling session with dietitian will last 30 minutes, and 7 follow-up sessions will last 20 minutes. | Behavioural | Catered diet group, Diet guidance sessions group |
| Dietary counselingParticipants will receive dietary counseling weekly on Zoom for up to 30 minutes. Dietitian will meet with participants to explain benefits of adhering to diet therapy. | Behavioural | Catered diet group, Diet guidance sessions group |
| Feedback sessionsParticipants will be involved in one-time 50-minute feedback session over Zoom with dietitian and principal investigator. During the session, participants will discuss preferred foods/recipes during active disease, likeability of recipes, ease of recipe preparation, dietary adherence, and healthy food affordability. | Behavioural | Catered diet group, Diet guidance sessions group |
Primary outcome
Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)
Time frame: Up to 8 weeks
Will be measured with SCCAI.
1 secondary outcome
Fecal calprotectin
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- 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.
Oriana Damas, MD, MSCTI principal investigator
University of Miami Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catered diet, Diet guidance sessions and Dietary counseling in people with Ulcerative Colitis, run by University of Miami 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriana Damas, MD, MSCTI (305 243-6405, omazorra@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.