Trial Search Results

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 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: CocoaVia┬«
  • Other: Placebo

Phase:

Phase 1/Phase 2

Eligibility


Inclusion 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

Exclusion Criteria:

   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)

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Martha S Tingle, RN
650-724-2742
Recruiting