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

Part of paid clinical trials in Duarte, California.

Sponsor
Stephen Freedland
Study ID
NCT05832086
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fasting Mimicking Diet (FMD) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 13, 2023
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fasting Mimicking Diet
    Intermittent fasting using a fasting mimicking diet
  • Placebo Comparator: Standard Anti-Cancer Diet
    Standard Anti-Cancer Diet

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beckman Research Institute of the City of HopeDuarteCalifornia91010
Tanya Dorff, MD
[email protected]
(626) 256-4673
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Stephen Freedland, MD
[email protected]
310-423-3497
Gillian Gresham, PhD (SUB_INVESTIGATOR)
Edwin Posadas, MD (SUB_INVESTIGATOR)
Mourad Tighiouart, PhD (SUB_INVESTIGATOR)
Sungyong You, PhD (SUB_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Pao-Hwa Lin, PhD
[email protected]
(919) 660-6685
Daniel George, MD (SUB_INVESTIGATOR)
Matthew Labriola, MD (SUB_INVESTIGATOR)

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By research site
Beckman Research Institute of the City of Hope· Duarte, CACedars-Sinai Medical Center· Los Angeles, CADuke University· Durham, NC

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