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

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 t

Trial Details

NCT ID
NCT05832086
Phase
PHASE2
Sponsor
Stephen Freedland
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Fasting Mimicking Diet (FMD)
  • Standard Anti-Cancer Diet
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed …
  • Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or daro…
  • Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

For full eligibility, visit ClinicalTrials.gov.

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