Ulcerative Colitis
Tailored Anti-Inflammatory Diet Study for Americans With Ulcerative Colitis
This study is testing how a culturally tailored anti-inflammatory diet affects disease remission and biomarkers in Americans ages 16–75 with ulcerative colitis.
Registry title: Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
1 recruiting U.S. site ↓Study at a glance
- Age
- 16 Years–75 Years
- Treatment
- Catered diet or Diet guidance sessions
- Design
- Randomized · Single
- Central study contact
- Oriana Damas, MD, MSCTI305 243-6405omazorra@med.miami.edu
- Sponsor
- University of Miami
Research question
What effect does a culturally tailored anti-inflammatory diet have on disease remission and biomarkers of dietary response in American patients with ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 16–75 who self-identify as American.
- Participants must have an ulcerative colitis diagnosis documented in their medical records.
- The registry requires a Simple Clinical Colitis Activity Index score of 3–9 and no more than 12 bowel movements per day.
- Participants must have fecal calprotectin above 150 mg/dL and stable ulcerative colitis medications for the previous three months.
- The listed recruiting location is the University of Miami Health System in Miami, Florida.
Participation overview
What participation may involve
Participation may involve an eight-week catered diet, virtual diet guidance and counseling, daily food-intake records, and a one-time feedback session. The registry does not clearly explain how these activities are divided or sequenced in the crossover design. What participation may involve: - Receive three catered meals daily for eight weeks, delivered to the home each week, and record daily food intake. - Attend an initial virtual diet-guidance session of about 30 minutes and seven weekly follow-up sessions of about 20 minutes. - Receive weekly grocery gift cards during the diet-guidance intervention. - Attend weekly dietary counseling by Zoom for up to 30 minutes. - Join one 50-minute Zoom feedback session about food preferences, recipe preparation, adherence, and affordability. The catered diet lasts eight weeks, and each listed study arm is described as lasting up to eight weeks. The total duration across the crossover study is not stated. Reported remote activities include weekly diet-guidance sessions, weekly Zoom counseling, and one Zoom feedback session. The registry does not provide a complete schedule of screening, clinic, or assessment visits.
Study interventions
What participants may receive or do
- Catered diet: For eight weeks, participants receive breakfast, lunch, and dinner delivered to their homes weekly. The diet emphasizes whole American staple foods with few additives, and participants record their daily food intake.
- Diet guidance sessions: Participants receive weekly virtual guidance from a dietitian about food safety, preparation, and cooking. The registry describes one 30-minute initial session, seven 20-minute follow-ups, and weekly grocery gift cards.
- Dietary counseling: Participants receive weekly dietary counseling by Zoom for up to 30 minutes with a dietitian, including discussion of adherence to the diet therapy.
- Feedback sessions: Participants join one 50-minute Zoom session with a dietitian and the principal investigator to discuss food and recipe preferences, preparation, adherence, and affordability.
Study design
How the comparison works
This is an interventional, randomized crossover study of supportive dietary care. The two listed groups are each described as lasting up to eight weeks, but both arm listings name the same four activities, so their sequence and differences are unclear. Participants are randomly assigned within the crossover design. The study is single-masked, with participants identified as the masked group. The crossover design indicates that participants move between study conditions, but the registry does not clearly distinguish the conditions or their order because both arms list all four interventions.
Reported activities
Procedures and tests
- Disease symptoms are assessed with the Simple Clinical Colitis Activity Index, with clinical response measured after the diet intervention.
- Fecal calprotectin is measured to assess change during the study.
- Participants record their food intake each day during the catered-diet period.
- Participants attend virtual diet-guidance and dietary-counseling sessions with a dietitian.
- A one-time feedback session gathers participants' views on recipes, preparation, adherence, and food affordability.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- An ulcerative colitis diagnosis must be documented in the medical record.
- Participants must self-identify as American.
- The stated age range is 16–75 years.
- The Simple Clinical Colitis Activity Index must be 3–9, with no more than 12 bowel movements daily.
- Fecal calprotectin must be above 150 mg/dL, as written in the registry.
- Ulcerative colitis medications must have been stable for the previous three months.
- Participants must find the listed American foods acceptable.
- There must have been no inflammatory bowel disease-related hospitalization in the previous month.
Possible reasons someone may not be able to join
- A Crohn's disease diagnosis is listed as an exclusion.
- Prior ileoanal anastomosis, also called a J-pouch, or diversion is excluded.
- The exclusion list states there should be no Clostridium difficile or other enteric infection during the previous four weeks.
- The exclusion list states there should be no probiotic use during the previous four weeks.
- People currently following a specific-carbohydrate, Mediterranean, or anti-inflammatory diet are excluded.
- Active cancer or a condition that limits the ability to follow the diet, including heart failure or end-stage renal disease, is excluded.
- Pregnancy, breastfeeding, or planning pregnancy during the study period is excluded.
- Use of total parenteral nutrition at screening or during the study is excluded.
- People expected to need antibiotics during the study period are excluded.
- Other significant or life-threatening health conditions are listed as exclusions.
Important unknowns
What the record does not make clear
- Each arm and the catered diet are described as lasting up to eight weeks, but the total duration and timing of the crossover periods are not reported.
- Several weekly virtual sessions are described, but the registry does not give a complete schedule for screening, clinic visits, sample collection, or follow-up.
- The registry requires stable disease medication for three months but does not state which medications may continue or whether changes are allowed during the study.
- The exclusion section says there should be no probiotic use in the previous four weeks, but it does not explain whether stopping probiotics is permitted or whether other washout rules apply.
- The registry does not describe rescue treatment or procedures for worsening ulcerative colitis symptoms.
- The registry does not state whether colonoscopy, sigmoidoscopy, or another endoscopic procedure is required.
- The registry does not explain which study-related or medical costs are covered or billed to insurance.
- Weekly grocery gift cards are reported for diet-guidance sessions, but the amount, eligibility, and any other compensation are not stated.
- The registry does not state whether transportation, parking, lodging, or other travel expenses are supported.
- Meals are delivered and several sessions use Zoom, but the registry does not say whether screening and assessments can be completed remotely.
- The inclusion section requires no inflammatory bowel disease-related hospitalization in the previous month, while the exclusion section separately lists “No recent hospitalizations” as an exclusion, creating contradictory polarity.
- Both crossover arms list the same four interventions, so the activities assigned to each period and their sequence are not clear.
Before contacting the site
Questions for the study team
- What does each randomized crossover sequence involve, and which activities occur in each period?
- What is the complete participation timeline, including screening, crossover periods, tests, and follow-up?
- Which visits and sample collections require travel to Miami, and which can be completed remotely?
- Which ulcerative colitis medicines, supplements, and probiotics may continue during the study?
- What happens if ulcerative colitis symptoms worsen or antibiotics become necessary?
- How should the hospitalization criteria be interpreted?
- Are colonoscopy, sigmoidoscopy, blood tests, or additional stool collections required?
- What costs are covered, what is the grocery gift-card amount, and is travel support available?
Before changing care
Questions for your gastroenterologist
- Would keeping my current ulcerative colitis treatment stable for this study be appropriate given my recent disease course?
- How should symptom worsening or a possible need for antibiotics be managed while the research team is directing the diet intervention?
- How do the study's dietary approach and monitoring compare with approved treatment and nutrition options for my ulcerative colitis?
- How should my gastroenterology team and the research team coordinate medication decisions, symptom monitoring, and fecal-calprotectin results?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 and administration
- Organization
- University of Miami
- Organization class
- Other
- Organization study ID
- 20240857
- Lead sponsor
- University of Miami
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Crossover
- Primary purpose
- Supportive Care
- Masking
- Single
- Who is masked
- Participant
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Catered diet group
Participants will be in this arm for up to 8 weeks.
Interventions: Behavioral: Catered diet, Behavioral: Diet guidance sessions, Behavioral: Dietary counseling, Behavioral: Feedback sessions
Experimental
Diet guidance sessions group
Participants will be in this arm for up to 8 weeks.
Interventions: Behavioral: Catered diet, Behavioral: Diet guidance sessions, Behavioral: Dietary counseling, Behavioral: Feedback sessions
Interventions
Behavioral
Catered diet
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.
Behavioral
Diet guidance sessions
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.
Behavioral
Dietary counseling
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.
Behavioral
Feedback sessions
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.
Eligibility
16 Years–75 Years
All
Not accepted
Inclusion criteria (8)
- Documented diagnosis with ulcerative colitis from medical records.Registry-derived · unreviewed
- Self-Identify as AmericanRegistry-derived · unreviewed
- Ages 16-75Registry-derived · unreviewed
- SCCAI between 3-9 (no greater than 12 bowel movements a day)Registry-derived · unreviewed
- Fecal calprotectin \> 150mg/dl.Registry-derived · unreviewed
- On stable medications for their disease for the past 3 monthsRegistry-derived · unreviewed
- Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)Registry-derived · unreviewed
- No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.Registry-derived · unreviewed
Exclusion criteria (14)
- Diagnosis of Crohn's Disease (CD).Registry-derived · unreviewed
- Prior ileoanal anastomosis (J-pouch) or diversionRegistry-derived · unreviewed
- No recent hospitalizations on the last 4 weeksRegistry-derived · unreviewed
- No Clostridium difficile or enteric infections on the last 4 weeksRegistry-derived · unreviewed
- No use of probiotics on the last 4 weeksRegistry-derived · unreviewed
- Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory dietRegistry-derived · unreviewed
- No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)Registry-derived · unreviewed
- Pregnancy, breastfeeding or planning to become pregnant during study periodRegistry-derived · unreviewed
- Use of Total Parenteral Nutrition at the time of screening and during the study periodRegistry-derived · unreviewed
- Other significant or life-threatening co-morbiditiesRegistry-derived · unreviewed
- The need for antibiotic use during the study periodRegistry-derived · unreviewed
- Adults unable to consentRegistry-derived · unreviewed
- Ages less than 16 and \> 75 years oldRegistry-derived · unreviewed
- PrisonersRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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.
Secondary outcome
Fecal calprotectin
Time frame: Up to 8 weeks
Change in fecal calprotectin.
Recruiting locations in the United States
University of Miami Health System
RecruitingMiami, Florida, 33136, United States
Niurka Colina, CRC305 243-6405nxc610@miami.edu
Michael Mijares305 243-6405mmijares74@med.miami.edu
Oriana Damas, MD, MSCTI
Central study contacts
Registry dates
- First posted
- Jan 20, 2025
- Primary completion
- Sep 1, 2030
- Overall completion
- Sep 1, 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.