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NCT02158897 · ClinicalTrials.gov registry record · Phase 1
Multi-cycle Prolon Diet
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT02158897: Completed Phase 1 study, sponsored by University of Southern California.
NCT02158897 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158897, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study Summary
Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factors associated with aging and age-related disease in rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in a pilot human trial. The objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. The investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
Primary Outcome
Phase I: To obtain preliminary estimates of the feasibility and safety of a low calorie Prolon diet in adult subjects.
Interventions
- OTHER Prolon diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02158897 record still lists
NCT02158897 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 1 intervention - of which Prolon diet is the first listed.
NCT02158897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02158897 about?
NCT02158897 is a clinical study titled "Multi-cycle Prolon Diet". Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factor...
What is the current status of trial NCT02158897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2013-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02158897?
The interventions under investigation include: Prolon diet (OTHER).
Who is sponsoring clinical trial NCT02158897?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02158897's enrollment target sits among peer trials
102 543rd of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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