Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis Remission

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mediterranean Diet
  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.
• Поведенческое Mediterranean Diet + Time-Restricted Feeding
  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.
• Поведенческое Standard Dietary Advice
  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.

Первичные конечные точки

• Change in fecal short-chain fatty acid (SCFA) levels [Срок оценки: Baseline to 12 weeks]

Вторичные конечные точки (1)

• Change in fecal calprotectin [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Pontificia Universidad Católica de Chile — Santiago

Идентификаторы

NCT: NCT07752446 · 250706002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗