drugset / Trial / NCT03123068
Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-04-17
- Primary completion
- 2018-12-14
- Completion
- 2018-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CocoaVia® | Unknown | 1000 mg | Oral |
Indications
No indication recorded.