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RECRUITING Phase 2

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

NCT05832086 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • BEHAVIORAL Fasting Mimicking Diet (FMD)
  • BEHAVIORAL Standard Anti-Cancer Diet

Study Locations (3)

California

  • Beckman Research Institute of the City of Hope — Duarte
  • Cedars-Sinai Medical Center — Los Angeles

North Carolina

  • Duke University — Durham

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2023-09-13
Est. Completion 2029-03-30
Phase Phase 2

Sponsor

Stephen Freedland

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05832086

The ClinicalTrials.gov registry entry for NCT05832086 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stephen Freedland, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions — of which Fasting Mimicking Diet (FMD) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05832086 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05832086 about?

NCT05832086 is a clinical study titled "Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes". 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. ...

What is the current status of trial NCT05832086?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2023-09-13. Estimated completion is 2029-03-30.

What conditions does trial NCT05832086 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05832086?

The interventions under investigation include: Fasting Mimicking Diet (FMD) (BEHAVIORAL), Standard Anti-Cancer Diet (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05832086?

This trial is sponsored by Stephen Freedland, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05832086 being conducted?

This trial has 3 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial