NCT04147585已完成不适用
Effects of an Intermittent Reduced Calorie Diet on Crohn's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of Participants with Clinical response as per CDAI (70 points)
研究概览
简要总结
The purpose of this study is to see how an Intermittent Calorie Reduced Diet (IRCD) that mimics fasting (also known as a fasting mimicking diet, FMD) effects inflammation in patients with mild to moderate Crohn's disease (CD). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and CD are very limited. Diets that mimick fasting have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide rationale for its use to treat CD.
详细描述
As above
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate Crohn's disease (CDAI score 151-450)
- •Between the ages of 18-70 (inclusive)
排除标准
- •Women who are pregnant, nursing or expect to be pregnant
- •Individuals allergic to nuts
- •Individuals with a body mass index (BMI) lower than 18
- •Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
- •Individuals who have been severely weakened by a disease or medical procedure
- •Individuals who are taking medication which may not be safely consumed with a calorie restricted diet
- •Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia
- •Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
- •Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%)
- •Individuals with a history of syncope
- •Individuals with dietary needs incompatible with the IRCD meal plan
- •Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet
- •Patients on a calorie restricted diet will also be excluded
- •Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine,total colectomy, proctocolectomy, ileoanal pouch will be excluded (not excluded are patients with resection of terminal ileum, resection of short strictures of the small intestine, hemicolectomy).
结局指标
主要结局
Number of Participants with Clinical response as per CDAI (70 points)
时间窗: Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Defined as reduction of the CDAI of at least 70 points or achieving a CDAI score ≤ 150.
次要结局
- Number of Participants with Clinical remission as per CDAI(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Number of Participants with Clinical response as per CDAI (100 points)(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Number of Participants with Clinical response as per CDAI (70 points)(Assessed 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Change in C-reactive protein (CRP) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.(Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Change in Erythrocyte Sedimentation Rate (ESR) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.(Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.(Baseline versus within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Patient global assessment(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Effect of IRCD on endoscopic outcomes(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)(Assessed within 6 days after 3rd cycle of IRCD. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
研究者
Sidhartha Ranjit Sinha
Assistant Professor of Medicine (Gastroenterology and Hepatology)
Stanford University
研究点 (2)
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