Recruiting
Phase 2

Fasting-Mimicking Diet

Sponsor:

Stephen Freedland

Code:

NCT05832086

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fasting Mimicking Diet (FMD)

Standard Anti-Cancer Diet

Study Details

Brief 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

Study ID

NCT05832086

Start date

Sep 13, 2023

Status verified date

Aug, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fasting Mimicking Diet

Intermittent fasting using a fasting mimicking diet

placebo comparator: Standard Anti-Cancer Diet

Standard Anti-Cancer Diet

Interventions

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.

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.

Primary outcome measure

  • Response to cancer treatment [ Time Frame: 6 Month visit ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Stephen Freedland, MD

310-423-3497Stephen.Freedland@cshs.org

Locations

Beckman Research Institute of the City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Tanya Dorff, MD

(626) 256-4673tdorff@coh.or

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Stephen Freedland, MD

310-423-5842Stephen.Freedland@csmc.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Pao-Hwa Lin, PhD

(919) 660-6685lin00004@mc.duke.edu

More Information

Sponsor

Stephen Freedland

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Fasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stephen Freedland on 2026-08-10.