Last reviewed · How we verify
NCT05832086
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Phase 2 trial testing Fasting Mimicking Diet (FMD) in Prostate Adenocarcinoma in 138 participants. Currently enrolling.
30 September 2028
Quick facts
| Lead sponsor | Stephen Freedland |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 138 |
| Start date | 13 September 2023 |
| Primary completion | 30 September 2028 |
| Estimated completion | 30 March 2029 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Fasting Mimicking Diet (FMD)
- Standard Anti-Cancer Diet
Conditions studied
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
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):
-
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 -
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:
- PubMed search for NCT05832086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fasting Mimicking Diet (FMD)
Trials testing the same drug.
- NCT04529161 — Olfactory and Taste Changes During Fasting Mimicking Diet (FMD) · NA · completed
Other recruiting trials for Prostate Adenocarcinoma
Currently open trials in the same condition.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
- NCT07025369 — Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With H · Phase 2 · recruiting
- NCT06967961 — Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05832086 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stephen Freedland
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05832086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing