Ulcerative Colitis (Disorder)MEDITIME-UCNCT07752446
Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis Remission
A study testing Mediterranean Diet, Mediterranean Diet + Time-Restricted Feeding and Standard Dietary Advice in people with Ulcerative Colitis (Disorder) and Inflammatory Bowel Disease (IBD), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This study will evaluate whether a 12-week dietary intervention can improve gut health, inflammation, and quality of life in adults with ulcerative colitis in remission. Participants will be randomly assigned to one of three groups: a Mediterranean diet, a Mediterranean diet combined with time-restricted feeding… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis (Disorder), Inflammatory Bowel Disease (IBD)
- What is being tested?
- Mediterranean Diet, Mediterranean Diet + Time-Restricted Feeding and Standard Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChile
- Study dates
- 10 Apr 2026to 1 Jun 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years
- Diagnosis of ulcerative colitis
- Clinical remission for at least 6 months
- Fecal calprotectin < 250 µg/g in the last 3 months
- Daily eating window ≥ 11 hours
Who cannot join
- Active ulcerative colitis
- History of gastrointestinal surgery
- Liver or kidney disease
- Pregnancy
- Eating disorders
- Use of supplements (protein, antioxidants, probiotics)
- Current restrictive diets (vegetarian, vegan, gluten-free, low-FODMAP)
- High levels of physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan
María Balcells, MD, +56955048170, proyectos.didemuc@uc.cl
About this study
Official title: Mediterranean Diet and Time-Restricted Feeding Intervention to Improve Gut Health, Quality of Life and Inflammation in Patients With Ulcerative Colitis in Remission: A Pilot Randomized Controlled Trial
This study will evaluate whether a 12-week dietary intervention can improve gut health, inflammation, and quality of life in adults with ulcerative colitis in remission.
Participants will be randomly assigned to one of three groups: a Mediterranean diet, a Mediterranean diet combined with time-restricted feeding (eating within an 8-hour window each day), or standard dietary advice. The Mediterranean diet emphasizes fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, while limiting processed foods and red meat.
Read more
The main outcome will be changes in short-chain fatty acids in stool samples, which are markers of gut health. Additional outcomes include changes in inflammation markers, gastrointestinal symptoms, and quality of life.
The results of this study may help identify effective dietary strategies to support patients with ulcerative colitis.
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by periods of remission and relapse, associated with alterations in the gut microbiota, immune dysregulation, and impaired intestinal barrier function. Current treatments focus on controlling inflammation; however, there is a growing interest in non-pharmacological strategies, including dietary interventions, to improve disease outcomes and quality of life.
The Mediterranean diet has been associated with anti-inflammatory effects, improved gut microbiota composition, and increased production of short-chain fatty acids (SCFAs), which play a key role in maintaining intestinal homeostasis. Time-restricted feeding (TRF), a form of intermittent fasting that limits daily food intake to a specific time window, has shown potential metabolic and anti-inflammatory benefits in preclinical and human studies. However, evidence on the combined effects of these interventions in patients with UC is limited.
This study is a pilot randomized controlled trial designed to evaluate the effects of a 12-week intervention with a Mediterranean diet alone or in combination with TRF on gut health, inflammation, and quality of life in patients with UC in remission.
A total of 45 participants will be randomized in a 1:1:1 ratio into three groups: (1) Mediterranean diet, (2) Mediterranean diet combined with TRF (16-hour fasting and 8-hour eating window), and (3) standard dietary advice (control group). Nutritional plans will be individualized and isocaloric.
Participants will be assessed at baseline, week 6, and week 12. The primary outcome is the change in fecal SCFA levels, measured using gas chromatography. Secondary outcomes include changes in fecal calprotectin, C-reactive protein, gastrointestinal symptoms, and quality of life assessed by validated questionnaires.
This study aims to generate preliminary evidence on the effectiveness and feasibility of combined dietary interventions in UC, supporting future larger-scale clinical trials.
- Being tested
- Mediterranean Diet, Mediterranean Diet + Time-Restricted Feeding, Standard Dietary Advice
- Keywords
- Mediterranean Diet, Short-Chain Fatty Acids, Dietary Intervention, Time-Restricted Feeding, Ulcerative Colitis, Inflammation
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Intermittent Fasting, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Participants will receive individualized nutritional counseling to follow a Mediterranean diet, emphasizing high intake of fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, and reduced consumption of red meat and ultra-processed foods. Dietary plans will be tailored to individual energy requirements.
Mediterranean Diet + Time-Restricted FeedingBehavioural
Participants will follow a time-restricted feeding protocol (16:8), consisting of a daily 16-hour fasting period and an 8-hour eating window (12:00-20:00). During the eating window, participants will consume meals based on Mediterranean diet guidelines, with individualized dietary counseling to ensure adequate nutritional intake.
Standard Dietary AdviceBehavioural
Participants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis. This includes general recommendations for a balanced diet without specific emphasis on Mediterranean dietary patterns or time-restricted feeding.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Participants will receive individualized nutritional counseling to follow a Mediterranean diet, emphasizing fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, while limiting red meat and ultra-processed foods. Receives: Behavioral: Mediterranean Diet |
| Mediterranean Diet + Time-Restricted Feeding | Experimental | Participants will follow a Mediterranean diet combined with time-restricted feeding (16:8), consisting of an 8-hour eating window and a 16-hour fasting period Receives: Behavioral: Mediterranean Diet + Time-Restricted Feeding |
| Standard Diet | Active comparator | Participants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis. Receives: Behavioral: Standard Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal short-chain fatty acid (SCFA) levels
Fecal SCFA concentrations will be measured using gas chromatography and expressed as total and individual SCFA levels.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Change in fecal calprotectin
Fecal calprotectin levels will be measured as a marker of intestinal inflammation.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Apr 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: Mediterranean diet, Mediterranean diet combined with time-restricted feeding (16:8), or standard dietary advice (control). Each participant will remain in their assigned group for the entire 12-week intervention period.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Parada Daza, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752446
- Sponsor's protocol ID
- 250706002
- Acronym
- MEDITIME-UC
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Data contain sensitive health information, and consent for data sharing was not explicitly obtained from participants. Aggregated results will be made available through scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet and Time-Restricted Feeding Intervention to Improve Gut Health, Quality of Life and Inflammation in Patients With Ulcerative Colitis in Remission: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07752446
- Acronym / sponsor ID
- MEDITIME-UC / 250706002
- Keywords
- Mediterranean Diet, Short-Chain Fatty Acids, Dietary Intervention, Time-Restricted Feeding, Ulcerative Colitis, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
This study will evaluate whether a 12-week dietary intervention can improve gut health, inflammation, and quality of life in adults with ulcerative colitis in remission.
Participants will be randomly assigned to one of three groups: a Mediterranean diet, a Mediterranean diet combined with time-restricted feeding (eating within an 8-hour window each day), or standard dietary advice. The Mediterranean diet emphasizes fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, while limiting processed foods and red meat.
The main outcome will be changes in short-chain fatty acids in stool samples, which are markers of gut health. Additional outcomes include changes in inflammation markers, gastrointestinal symptoms, and quality of life.
The results of this study may help identify effective dietary strategies to support patients with ulcerative colitis.
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by periods of remission and relapse, associated with alterations in the gut microbiota, immune dysregulation, and impaired intestinal barrier function. Current treatments focus on controlling inflammation; however, there is a growing interest in non-pharmacological strategies, including dietary interventions, to improve disease outcomes and quality of life.
The Mediterranean diet has been associated with anti-inflammatory effects, improved gut microbiota composition, and increased production of short-chain fatty acids (SCFAs), which play a key role in maintaining intestinal homeostasis. Time-restricted feeding (TRF), a form of intermittent fasting that limits daily food intake to a specific time window, has shown potential metabolic and anti-inflammatory benefits in preclinical and human studies. However, evidence on the combined effects of these interventions in patients with UC is limited.
This study is a pilot randomized controlled trial designed to evaluate the effects of a 12-week intervention with a Mediterranean diet alone or in combination with TRF on gut health, inflammation, and quality of life in patients with UC in remission.
A total of 45 participants will be randomized in a 1:1:1 ratio into three groups: (1) Mediterranean diet, (2) Mediterranean diet combined with TRF (16-hour fasting and 8-hour eating window), and (3) standard dietary advice (control group). Nutritional plans will be individualized and isocaloric.
Participants will be assessed at baseline, week 6, and week 12. The primary outcome is the change in fecal SCFA levels, measured using gas chromatography. Secondary outcomes include changes in fecal calprotectin, C-reactive protein, gastrointestinal symptoms, and quality of life assessed by validated questionnaires.
This study aims to generate preliminary evidence on the effectiveness and feasibility of combined dietary interventions in UC, supporting future larger-scale clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: Mediterranean diet, Mediterranean diet combined with time-restricted feeding (16:8), or standard dietary advice (control). Each participant will remain in their assigned group for the entire 12-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Behavioral: Mediterranean DietParticipants will receive individualized nutritional counseling to follow a Mediterranean diet, emphasizing fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, while limiting red meat and ultra-processed foods. |
| Mediterranean Diet + Time-Restricted Feeding | Experimental | Behavioral: Mediterranean Diet + Time-Restricted FeedingParticipants will follow a Mediterranean diet combined with time-restricted feeding (16:8), consisting of an 8-hour eating window and a 16-hour fasting period |
| Standard Diet | Active comparator | Behavioral: Standard Dietary AdviceParticipants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 60 years
- Diagnosis of ulcerative colitis
- Clinical remission for at least 6 months
- Fecal calprotectin < 250 µg/g in the last 3 months
- Daily eating window ≥ 11 hours
Key exclusion criteria (8 listed)
- Active ulcerative colitis
- History of gastrointestinal surgery
- Liver or kidney disease
- Pregnancy
- Eating disorders
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 |
|---|---|---|
| Mediterranean DietParticipants will receive individualized nutritional counseling to follow a Mediterranean diet, emphasizing high intake of fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, and reduced consumption of red meat and ultra-processed foods. Dietary plans will be tailored to individual energy requirements. | Behavioural | Mediterranean Diet |
| Mediterranean Diet + Time-Restricted FeedingParticipants will follow a time-restricted feeding protocol (16:8), consisting of a daily 16-hour fasting period and an 8-hour eating window (12:00-20:00). During the eating window, participants will consume meals based on Mediterranean diet guidelines, with individualized dietary counseling to ensure adequate nutritional intake. | Behavioural | Mediterranean Diet + Time-Restricted Feeding |
| Standard Dietary AdviceParticipants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis. This includes general recommendations for a balanced diet without specific emphasis on Mediterranean dietary patterns or time-restricted feeding. | Behavioural | Standard Diet |
Primary outcome
Change in fecal short-chain fatty acid (SCFA) levels
Time frame: Baseline to 12 weeks
Fecal SCFA concentrations will be measured using gas chromatography and expressed as total and individual SCFA levels.
1 secondary outcome
Change in fecal calprotectin
Time frame: Baseline to 12 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 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Data contain sensitive health information, and consent for data sharing was not explicitly obtained from participants. Aggregated results will be made available through scientific publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet, Mediterranean Diet + Time-Restricted Feeding and Standard Dietary Advice in people with Ulcerative Colitis (Disorder) and Inflammatory Bowel Disease (IBD), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 8 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 7 Aug 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 Chile. 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 Alejandra Parada Daza, Phd (+56994751585, acparada@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal short-chain fatty acid (SCFA) levels (time frame: Baseline to 12 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 7 Aug 2026.