Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis Remission

NCT07752446 | Recruiting

• 1 other identifier: 250706002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Ulcerative Colitis (Disorder); Inflammatory Bowel Disease (IBD)

Keywords

Mediterranean Diet; Short-Chain Fatty Acids; Dietary Intervention; Time-Restricted Feeding; Ulcerative Colitis; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 weeks

Secondary Outcomes (1)

• Change in fecal calprotectin

  Baseline to 12 weeks

Study Arms (3)

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.

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

Behavioral: Mediterranean Diet + Time-Restricted Feeding

Standard Diet

ACTIVE COMPARATOR

Participants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis.

Behavioral: Standard Dietary Advice

Interventions

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

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.

Mediterranean Diet + Time-Restricted Feeding

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.

Standard Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Intermittent Fasting; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Fasting; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Alejandra Parada Daza, Phd

CONTACT

+56994751585; acparada@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nutritionist, PhD, MSc, Department of Nutrition and Dietetics, School of Health Sciences, Pontificia Universidad Católica de Chile

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: August 7, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)