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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). 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.
Primary Outcome
Blood samples will be collected to measure possible attenuation of surgery-evoked increase in NFkB signaling in innate immune cells shortly after surgery at specified time points. Phosphorylation of functional markers (activity) was expressed as the arcsinh-transformed value of the median value. Changes in activity over time were captured by building the arcsinh ratio between the arcsinh-value obtained in samples collected at a given time with the arcsinh-value obtained in samples collected at
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 |
What the finished NCT03123068 record still lists
NCT03123068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03123068 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123068's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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