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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in fecal short-chain fatty acid (SCFA) levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mediterranean Diet
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.
干预措施: Mediterranean Diet (Behavioral)
Mediterranean Diet + Time-Restricted Feeding
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
干预措施: Mediterranean Diet + Time-Restricted Feeding (Behavioral)
Standard Diet
Participants will receive standard dietary counseling based on current clinical guidelines for ulcerative colitis.
干预措施: Standard Dietary Advice (Behavioral)
结局指标
主要结局
Change in fecal short-chain fatty acid (SCFA) levels
时间窗: Baseline to 12 weeks
Fecal SCFA concentrations will be measured using gas chromatography and expressed as total and individual SCFA levels.
次要结局
- Change in fecal calprotectin(Baseline to 12 weeks)
研究者
Alejandra Parada Daza
Principal Investigator, Nutritionist, PhD, MSc, Department of Nutrition and Dietetics, School of Health Sciences, Pontificia Universidad Católica de Chile
Pontificia Universidad Catolica de Chile