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

NCT05832086 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-05-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Stephen Freedland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2028-09-30
Completion
2029-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832086 on ClinicalTrials.gov