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

Stephen Freedland

Status and phase: Enrolling; Phase 2

Conditions: Prostate Adenocarcinoma

Treatments: Behavioral: Standard Anti-Cancer Diet; Behavioral: Fasting Mimicking Diet (FMD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05832086

IIT2023-02-FREEDLAND-FAST-PRO

1R01CA280081-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
• Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
• 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.

Exclusion criteria

• Allergies to any ingredients listed on the Xentigen Ingredient List
• Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
• Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
• Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
• Body Mass Index (BMI) <20kg/m2
• Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months
• Self-reported weight loss ≥ 10% in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups, including a placebo group

Fasting Mimicking Diet

Experimental group

Description:

Intermittent fasting using a fasting mimicking diet

Treatment:

Behavioral: Fasting Mimicking Diet (FMD)

Standard Anti-Cancer Diet

Placebo Comparator group

Description:

Standard Anti-Cancer Diet

Treatment:

Behavioral: Standard Anti-Cancer Diet