Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study

Conditions
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Prostate Cancer, Metabolic Syndrome, Intermittent Fasting

Intervention / Treatment
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* Other: Fasting mimicking diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease. Exclusion Criteria: 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fasting mimicking diet|3 cycles of programmed nutrition using a fasting mimicking diet (Chemolieve (R)), each cycle consisting of 4 days. Pre and post nutritional cycles, clinical and metabolic assessments are taken, as per protocol. Allowing for a 3 month washout time, the 'post' assessment is planned approximately 6 months from the initial (pre) assessment.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Weight (in kilograms) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 
| Change in Baseline Blood Pressure (in millimeters of Mercury) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 
| Change in Baseline Waist Circumference (in centimeters) at 6 months | Metabolic health parameter | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 
| Change in Baseline Triglycerides Level (in millimoles per litre) at 6 months | Clinical lab results | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 
| Change in Baseline Total, LDL, and HDL Cholesterol (in millimoles per litre) at 6 months | Clinical lab results | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline EQ5D5L Health Questionnaire Score at 6 months | Structured Quality of Life Measure - Patients' self report of mobility, self-care, usual activities, pain/discomfort, anxiety/depression - No problem Slight problems Moderate problems Severe problems Unable to/extreme problems 5 questions Minimum score of 0, meaning good quality of life Maximum score of 25, meaning poor quality of life | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 
| Change in Baseline EQ5D5L Vertical Visual Analogue Scale Score at 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 imagine | 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 | Structured Tiredness/Fatigue Measures on Likert Scale - Patients' self report of fatigue symptoms - 0: Less than usual No more than usual More than usual 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 | Baseline and 3 months after Nutritional Cycle 3 (each cycle is 4 days per month), about 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting Mimicking Diet