NCT04292041

Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Galway Clinic · Network
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Metabolic Syndrome
• Intermittent Fasting

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2020-03-02
• Last updated: 2020-03-02

Locations

1 site across 1 country: Ireland