Short-Term Effects of a Low-FODMAP Diet, Adapted NICE Dietary Advice, and Adapted NICE Dietary Advice Combined With Intermittent Fasting on Symptoms and Quality of Life in Irritable Bowel Syndrome: A Three-Arm, Non-Randomized Controlled Dietary Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Irritable Bowel Syndrome Symptom Severity
研究概览
简要总结
The goal of this clinical trial is to compare the short-term effects of three dietary approaches in adults with irritable bowel syndrome (IBS): a low-FODMAP diet, adapted National Institute for Health and Care Excellence (NICE) dietary advice, and adapted NICE dietary advice combined with 16:8 intermittent fasting.
The main questions this study aims to answer are:
How do these three dietary approaches affect IBS symptom severity after two weeks? How do these three dietary approaches affect IBS-related quality of life after two weeks? The researchers hypothesize that the low-FODMAP diet will produce the greatest short-term reduction in IBS symptom severity. The study will also explore whether adding 16:8 intermittent fasting to adapted NICE dietary advice provides additional benefit.
Researchers will compare the three dietary groups to determine whether the changes in IBS symptoms and quality of life differ between the dietary approaches.
Participants will:
Follow one of the three dietary approaches for two weeks. Attend study visits at the beginning of the study, after one week, and after two weeks.
Keep records of their food and fluid intake. Complete questionnaires about IBS symptoms, quality of life, anxiety, and depression.
Record their stool form and frequency during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years Diagnosis of irritable bowel syndrome (IBS) according to the Rome IV criteria IBS subtype classified as IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), or IBS with mixed bowel habits (IBS-M)
排除标准
- •Celiac disease Inflammatory bowel disease History of cancer Diabetes Kidney disease Pregnancy Current adherence to an elimination diet
研究组 & 干预措施
Low-FODMAP Diet (LF)
Participants in this arm followed a researcher-designed low-FODMAP elimination diet for two weeks. The dietary intervention was delivered by a dietitian who had completed Monash University Low-FODMAP Diet Training.
干预措施: Low-FODMAP Diet (Behavioral)
Adapted NICE Dietary Advice (NICE)
Participants in this arm followed adapted NICE dietary advice for two weeks. The recommendations included eating regular meals and avoiding prolonged fasting, drinking at least 2 liters of water per day, limiting fruit intake to a maximum of three servings (240 g) per day, limiting tea and coffee to a maximum of three cups per day, and limiting alcohol and carbonated beverages. No specific restriction on fiber or FODMAP intake was applied.
干预措施: Adapted NICE Dietary Advice (Behavioral)
Adapted NICE Dietary Advice Plus Intermittent Fasting (NICE-IF)
Participants in this arm followed adapted NICE dietary advice combined with a 16:8 intermittent fasting regimen for two weeks. All meals were consumed within an 8-hour eating window, either from 11:00 to 19:00 or from 12:00 to 20:00, followed by a 16-hour fasting period. One or two snacks were permitted within the eating window. No specific restriction on fiber or FODMAP intake was applied.
干预措施: 16:8 Intermittent Fasting (Behavioral)
结局指标
主要结局
Change in Irritable Bowel Syndrome Symptom Severity
时间窗: Baseline to 2 weeks
IBS symptom severity was assessed using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). The total score ranges from 0 to 500, with higher scores indicating greater symptom severity. A reduction of at least 50 points was considered a clinically meaningful improvement.
次要结局
- Change in Irritable Bowel Syndrome-Specific Quality of Life(Baseline to 2 weeks)