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NCT03123068 · ClinicalTrials.gov registry record · Phase 1
Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT03123068: Completed Phase 1 study, sponsored by Stanford University.
NCT03123068 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 74 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123068, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This double-blind, placebo-controlled proof-of-concept clinical trial is intended to demonstrate that preemptive oral administration of cocoa flavanol for five days before surgery will attenuate the surgery-evoked increase of HMGB1 in blood plasma and NFkB signaling in innate immune cells shortly after surgery. A secondary aim is to capture preliminary patient-centered outcomes data and relate these outcomes to the intake of oral cocoa flavanol and surgery-evoked activation of the HMGB1-NFkB signaling axis. Participants will be randomized to receive either an over the counter supplement containing cocoa flavanols, or placebo, for 5 days before surgery.
Interventions
- OTHER Placebo
- DRUG CocoaVia®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2017-04-17 |
| Est. Completion | 2018-12-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03123068
The ClinicalTrials.gov registry entry for NCT03123068 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03123068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03123068 about?
NCT03123068 is a clinical study titled "Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery". This double-blind, placebo-controlled proof-of-concept clinical trial is intended to demonstrate that preemptive oral administration of cocoa flavanol for five days before surgery will attenuate the surgery-evoked increase of HMGB1 in blood plasma and NFkB signaling in innate immune cells shortly af...
What is the current status of trial NCT03123068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2017-04-17. Estimated completion is 2018-12-14.
What interventions are being tested in trial NCT03123068?
The interventions under investigation include: Placebo (OTHER), CocoaVia® (DRUG).
Who is sponsoring clinical trial NCT03123068?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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