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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
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.
Beckman Research Institute of the City of Hope
Duarte, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGResponse to cancer treatment
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
Time frame: 6 Month visit
Castration resistance 1
will be measured by Testosterone (ng/dl)
Time frame: 6 Month visit
Castration resistance 2
will be measured by PSA levels (ng/mL)
Time frame: 6 Month visit
Metabolic Toxicity 1
Will be measured by the changes in HbA1c
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 2
Will be measured by the changes in waist circumference
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 3
Will be measured by the changes in fat mass (assessed via bioelectrical expedience)
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 4
Will be measured by the changes in body weight
Time frame: Change from Baseline to 6 Month visit
Self-reported overall well-being
will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome.
Time frame: Change from Baseline to 6 Month visit
Self-reported energy levels
will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome.
Time frame: Change from Baseline to 6 Month visit
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