Status:
UNKNOWN
Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome
Lead Sponsor:
Galway Clinic
Conditions:
Prostate Cancer
Metabolic Syndrome
Eligibility:
MALE
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...
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 associat...
Eligibility Criteria
Inclusion
- Patients with biopsy-proven prostate cancer having features of a metabolic syndrome, receiving standard treatment options for their disease.
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04292041
Start Date
January 15 2019
End Date
June 15 2020
Last Update
March 2 2020
Active Locations (1)
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1
Galway Clinic
Galway, Ireland