RecruitingPhase 2NCT05832086

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

Sponsor

Stephen Freedland

Enrollment

138 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma

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.

Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is testing whether a "fasting-mimicking diet" — a special 5-day low-calorie diet that tricks the body into thinking it's fasting — can improve cancer control and metabolic health in men with advanced prostate cancer who are receiving hormone therapy. Participants will follow this diet periodically alongside their cancer treatment. **You may be eligible if...** - You are a man with metastatic castrate-sensitive prostate cancer (cancer that still responds to hormone-lowering treatments) - You are currently receiving or about to start hormone therapy combined with newer agents (abiraterone, enzalutamide, apalutamide, or darolutamide) - You speak English or Spanish and can be contacted by phone - Your BMI is 20 or higher **You may NOT be eligible if...** - You have allergies to any ingredients in the special diet - You have diabetes and are not stable on your medications - You are already following a fasting diet or using weight-loss medications - You have lost more than 10% of your body weight in the last 6 months - You have significant heart, liver, or lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFasting 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.

BEHAVIORALStandard 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.