Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Baseline Weight (in kilograms) at 6 months
研究概览
简要总结
This is a prospective observational cohort study of patients with prostate cancer who have a metabolic syndrome. The study aims to evaluate the role of intermittent fasting (fasting mimicking diet) in these patients. The primary end point is metabolic health and the secondary endpoint is quality of life.
详细描述
Cancer is a complex set of conditions which collectively comprise the second biggest cause of death in the western world. In addition, these diseases, along with their various treatments, are associated with significant illness, as well as a host of debilitating symptoms. Two very common problems are cancer fatigue, as well as metabolic changes which can cause much suffering in and of themselves. Patients with advanced cancers, as well as many patients undergoing surgery, radiation therapy as well as chemotherapy all complain of fatigue, to a greater or lesser extent. Many gain or lose weight, and develop associated metabolic changes in uninvolved body systems, which can cause a significant health burden on the patients, as well as the healthcare system as a whole.
Little is known about the mechanisms which underlie these symptoms. Various biologic processes have been implicated including inflammation and other changes in body metabolism. There is urgent need to better understand these processes, which cause so much suffering in cancer patients, so as to potentially develop more effective solutions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.
排除标准
- •Patients without a diagnosis of prostate cancer
- •Life expectancy less than 1 year
- •Children under the age of 18
- •Individuals who are allergic to nuts or soy
- •Individuals with a Body Mass Index (BMI) <18.5
- •Individuals who have been severely weakened by a disease or medical procedure
- •Individuals who are taking medications which may not be safely consumed with a calorie restricted diet unless authorised in writing by a licensed physician
- •Individuals with a history of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF <40% on any prior assessment
- •Individuals with a history of syncope (fainting) with calorie restriction or other medical co-morbidities
- •Individuals who have special dietary needs that are incompatible with the ProLon® meal plan
- •Individuals with liver or kidney disorders that may be affected by the very low glucose and protein content of the diet
结局指标
主要结局
Change in Baseline Weight (in kilograms) at 6 months
时间窗: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Metabolic health parameter
Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months
时间窗: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Metabolic health parameter
Change in Baseline Waist Circumference (in centimeters) at 6 months
时间窗: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Metabolic health parameter
Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months
时间窗: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Clinical lab results
Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months
时间窗: Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months
Clinical lab results
次要结局
- Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 6 months(Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months)
- Change in Baseline EQ5D5L Health Questionnaire Score at 6 months(Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months)
- Change in Baseline Chalder Fatigue Index Score at 6 months(Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months)
研究者
Professor Frank Sullivan
Medical Director, Department of Radiation Oncology
Galway Clinic