NCT04213729已完成不适用
A Holistic Diet Intervention for People With Crohn's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rate of adherence to fat intake
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of adherence to fat intake
时间窗: Week 36
Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
Change in fat intake
时间窗: Baseline, 8 weeks
Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
次要结局
- Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).(Baseline, Week 8)
- Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).(Baseline, Week 8)
- Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).(Baseline, Week 8)
- Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)(Baseline, Week 8)
- Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).(Baseline, Week 8)
- Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).(Baseline, Week 8)
- Change in the expression of Serum Amyloid A (SAA).(Baseline, Week 8)
研究者
Maria Abreu
Professor of Medicine
University of Miami
研究点 (2)
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