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NCT05832086 · ClinicalTrials.gov registry record · Phase 2
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
A Phase 2 study of Prostate Adenocarcinoma, sponsored by Stephen Freedland.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 3
- Study locations
NCT05832086 is a Phase 2 study of Prostate Adenocarcinoma that is actively recruiting participants, run by Stephen Freedland. The registered enrollment target is 138 participants, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05832086, a Phase 2 study of Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Stephen Freedland.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 3
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (36% lower). The listed sponsor is Stephen Freedland, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05832086 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.
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.
What interventions are being tested in trial NCT05832086?
The interventions under investigation include: Fasting Mimicking Diet (FMD) (BEHAVIORAL), Standard Anti-Cancer Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT05832086?
This trial is sponsored by Stephen Freedland, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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