Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome
- Conditions
- Prostate CancerIntermittent FastingMetabolic Syndrome
- Registration Number
- NCT04292041
- Lead Sponsor
- Galway Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 40
- Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Baseline Weight (in kilograms) at 6 months 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 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 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 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 Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months Clinical lab results
- Secondary Outcome Measures
Name Time Method 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 Structured Quality of Life Measure - Patients' self report on how good/bad their health is TODAY -
* One scale numbered from 0 to 100
* Minimum score of 0, meaning the worst health you can imagine
* Maximum score of 100, meaning the best health you can imagineChange 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 Structured Quality of Life Measure - Patients' self report of mobility, self-care, usual activities, pain/discomfort, anxiety/depression -
1. No problem
2. Slight problems
3. Moderate problems
4. Severe problems
5. Unable to/extreme problems
* 5 questions
* Minimum score of 0, meaning good quality of life
* Maximum score of 25, meaning poor quality of lifeChange 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 Structured Tiredness/Fatigue Measures on Likert Scale - Patients' self report of fatigue symptoms -
0: Less than usual
1. No more than usual
2. More than usual
3. Much more than usual
* 6 questions
* minimum score of 0, meaning no fatigue due to illness
* maximum score of 18, meaning chronic fatigue due to illness
Trial Locations
- Locations (1)
Galway Clinic
🇮🇪Galway, Ireland