drugset / Trial / NCT03123068

Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery

NCT03123068 ↗

Phase 1/2 Completed 74 enrolled Stanford University
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

EvaluationDrugModalityDoseRoute
Comparator CocoaVia® Unknown 1000 mg Oral

Indications

No indication recorded.