At a glance
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Cocoa Flavanols for Modulating the Surgical Immune Response and Accelerating Clinical Recovery
In Brief
A Phase 2 clinical trial evaluating CocoaVia® and Placebo for Surgical Recovery. Completed, enrolled 74 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule.
The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment.