Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
Cocoa Flavanols for Modulating the Surgical Immune Response and Accelerating Clinical Recovery
Eligibility Criteria
- 1. 18 - 90 years of age 2. Male or female 3. Planning to undergo total hip or knee arthroplasty, either primary or revision 4. Fluent in English 5. Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures
- 1. Infectious disease within the last month 2. Immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine) 3. Chronic medication with potential immune-modulatory effects (e.g., daily oral morphine-equivalent intake > 30 mg) 4. Major surgery within the last 3 months or minor surgery within the last month. 5. History of substance abuse (e.g., alcoholism, drug dependency) 6. Pregnancy 7. Autoimmune disease interfering with data interpretation (e.g. lupus) 8. Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function 9. Active malignancy 10. Participation in another clinical trial of an investigational drug or device within the last month that, in the investigator's opinion, would create an increased risk to the participant or compromise the integrity of the study 11. Other conditions compromising a participant's safety or the integrity of the study 12. Allergy to active ingredient of CocoaVia®, the study intervention. 13. Frequent consumption of dark chocolate and flavanol containing foods (e.g. black tea, red wine, apples)
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Martha S Tingle, RN
650-724-2742
View on ClinicalTrials.gov
