Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis Remission

ConditionsUlcerative Colitis (Disorder)Inflammatory Bowel Disease (IBD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorPontificia Universidad Catolica de Chile

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active ulcerative colitis

History of gastrointestinal surgery

Liver or kidney disease

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

Mediterranean Diet
Behavioral
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 Feeding
Behavioral
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 Advice
Behavioral
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.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Mediterranean DietExperimental treatment 1 intervention

Group B: Mediterranean Diet + Time-Restricted FeedingExperimental treatment 1 intervention

Group C: Standard DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

Change in fecal calprotectin

Fecal calprotectin levels will be measured as a marker of intestinal inflammation.

Time frame

Baseline to 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pontificia Universidad Catolica de Chile

Lead sponsor

Source ClinicalTrials.gov

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