NCT05832086

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Stephen Freedland · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians. This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Fasting Mimicking Diet (FMD)	Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
BEHAVIORAL	Standard Anti-Cancer Diet	Will receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week.

Timeline

• Start date: 2023-09-13
• Primary completion: 2028-09-30
• Completion: 2029-03-30
• First posted: 2023-04-27
• Last updated: 2026-04-07

Locations

3 sites across 1 country: United States