Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.

Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day.

Surgical Recovery

CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule.

CocoaVia®

The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment.

Placebo

Stanford University Hospital

Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery

Cocoa Flavanols for Modulating the Surgical Immune Response and Accelerating Clinical Recovery

Blood samples will be collected to measure possible attenuation of surgery-evoked increase in NFkB signaling in innate immune cells shortly after surgery at specified time points as follows: ~ 7 days before surgery, 1 hour before, and 1 and 24 hours after surgery.

Blood samples will be collected to measure possible attenuation of surgery-evoked increase of HMGB1 in blood plasma shortly after surgery at specified time points as follows: ~ 7 days before surgery, 1 hour before, and 1 and 24 hours after surgery.

Participants will wear an Actigraph watch beginning 5 days before surgery, and for 6 weeks following surgery. The watch will objectively and continuously report a participant's activity and sleep.

Participants will complete the WOMAC questionnaire (function subscale) before surgery, daily during hospitalization, and weekly through week 6 post op.

Participants will complete the WOMAC questionnaire (pain subscale) before surgery, daily during hospitalization, and weekly through week 6 post op.

Participants will complete the SRS questionnaire (Surgery Recovery Scale) before surgery, daily during hospitalization, and weekly through week 6 post op to evaluate post op fatigue.

Martin Angst

Professor of Anethesioloogy, Perioperative and Pain Medicine

Stanford University

Placebo and active treatments will be formulated in identical capsules, and bottled and labeled with coded study numbers that will allow for all parties to remain blinded throughout the data collection phase.

Cardiovascular Disease

Cancer

2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Cocoa extract

Multivitamin

Cocoa extract placebo

Multivitamin placebo

Brigham and Women's Hospital

Fred Hutchinson Cancer Research Center

COcoa Supplement and Multivitamin Outcomes Study

CVD events include myocardial infarction, stroke, coronary revascularization procedures, and cardiovascular deaths. CVD events are confirmed by review of discharge summaries, ECG's, laboratory reports, test reports, and death certificates.

Diagnoses of invasive cancer are confirmed by review of discharge summaries, pathology reports, operative reports, and diagnostic or treatment procedure reports, including both inpatient and outpatient procedures.

Internet-based neuropsychological testing battery, including tests of novel object recognition, spatial learning, attention, inhibition, and executive control; face-to-face and computerized assessments of verbal memory, psychomotor speed, and executive function, working memory and organization; concentration and processing speed; visual recall; oral reading; receptive vocabulary; cognitive flexibility; attention; inhibitory control

Balance tests, grip strength, timed chair stands, walking speed

JoAnn E. Manson, MD

Principal Investigator

Mars, Inc.

Pfizer

Columbia University

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content and 2) before and 2 hours following consumption of a beverage with "low" flavanol content.

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "low" flavanol content and 2) before and 2 hours following consumption of a beverage with "high" flavanol content.

The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "high" flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "low" flavanol content.
During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.

High Flavanol First Then Low Flavanol

The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "low" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "high" flavanol content.
During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.

Low Flavanol First Then High Flavanol

Total

Sex: Female, Male

Region of Enrollment

Mean Blood Pressure

Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial).
CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

High Flavanol

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with "low" flavanol content (placebo trial).
Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

Low Flavanol

Cutaneous Blood Flow Response to Local Heating of the Skin.

Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content, and 2) before and 2 hours following consumption of a beverage with "low" flavanol content.
The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "low" flavanol content, and 2) before and 2 hours following consumption of a beverage with "high" flavanol content.
The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

Pulse Wave Velocity / Arterial Stiffness

The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "high" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "low" flavanol content.
During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.

The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with "low" flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with "high" flavanol content.
During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption.

Overall Study

Dr. R. Matthew Brothers

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "low" flavanol content, and 2) before and 2 hours following consumption of a beverage with "high" flavanol content.
The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

Aging

The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

High Flavanol first then Low Flavanol

The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

flavanol/záhať

Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery

COcoa Supplement and Multivitamin Outcomes Study

Role of Flavanols In Cardiovascular Function in Healthy Aging

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