The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Clinical response as per partial Mayo score
研究概览
简要总结
The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). 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 UC are very limited. Fasting mimicking diets (FMD) 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 three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.
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 Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)
- •Age of 18-70 at start of study (inclusive)
排除标准
- •Women who are pregnant or 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 as defined by the patient's physician, 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 FMD 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 caloric 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, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.
结局指标
主要结局
Clinical response as per partial Mayo score
时间窗: Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 a decrease from baseline in the partial Mayo score of \>= 2 points and either a rectal bleeding subscore of \<=1 or a decrease in the rectal bleeding subscore of \>=1 point, or achieving a partial Mayo score \<2. The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
次要结局
- Clinical remission as per partial Mayo score(Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Clinical remission as per modified Mayo (mMayo) score(Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Clinical response as per mMayo score(Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.)
- Symptomatic remission as per Patient Reported Outcome (PRO2) score(Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 completing Cycle 3. 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 FMD on endoscopic outcomes(Comparison of disease score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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).(Comparison of CRP levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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).(Comparison of ESR levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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 Short Inflammatory Bowel Disease questionnaire (SIBDQ) score(Comparison of SIBDQ score up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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.(Comparison of calprotectin levels up to 14 days before starting Cycle 1, and within 6 days after completing Cycle 3. 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
Stanford University