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NCT05832086

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

Recruiting now Phase 2 Last updated 7 April 2026
What this trial tests

Phase 2 trial testing Fasting Mimicking Diet (FMD) in Prostate Adenocarcinoma in 138 participants. Currently enrolling.

Timeline
13 September 2023
Primary endpoint
30 September 2028
30 March 2029

Quick facts

Lead sponsorStephen Freedland
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment138
Start date13 September 2023
Primary completion30 September 2028
Estimated completion30 March 2029
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stephen Freedland

Who can join

Eligibility, male only, with Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Intermittent fasting and its impact on toxicities, symptoms and quality of life in patients on active cancer treatment.
    Li Sucholeiki R, Propst CL, Hong DS, George GC. · · 2024 · cited 4× · PMID 38574507 · DOI 10.1016/j.ctrv.2024.102725
  2. The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
    Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034

Verify or expand the search:

Other trials of Fasting Mimicking Diet (FMD)

Trials testing the same drug.

Other recruiting trials for Prostate Adenocarcinoma

Currently open trials in the same condition.

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Data sources for this page

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