An interventional study of Mediterranean Diet and Mediterranean Diet + Time-Restricted Feeding in Ulcerative Colitis (Disorder) and Inflammatory Bowel Disease (IBD), sponsored by Pontificia Universidad Catolica de Chile. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment
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.
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 45 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Mediterranean Diet
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
Behavioral: Mediterranean Diet + Time-Restricted Feeding
Participants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis.
Behavioral: Standard Dietary Advice
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.
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.
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.
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.
Time frame: Baseline to 12 weeks
Change in fecal calprotectin
Fecal calprotectin levels will be measured as a marker of intestinal inflammation.
Time frame: Baseline to 12 weeks
Plan to share: 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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