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

High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin

Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin

Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.

High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given

High Polyphenol Milk Chocolate

Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given

Low Polyphenol Milk

Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin
Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given

Nestle Noir 70 % Chocolate

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

Baseline HOMA (Homeostatic Model Assessment)index was evaluated at V1 (visit 1) scheduled 28 days after the screening visit (V0) without any chocolate intake. HOMA reflects the resistance to insulin and is obtained from glucose and insulin plasma concentrations at a given sampling timepoint, based on the following formula:
HOMA = Glucose (in mmol/L) X Insulin ( in mU/L)/ 22.5. Insulin resistance is defined by a HOMA index > 2.4. The highest the HOMA index is, the more pronounced the resistance to insulin is.

HOMA at the begining of product intake

HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index > 2.4

Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake

Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)

Endothelial Function After 12 Weeks of Product Intake

Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake

Cholesterol Profile After 12 Weeks of Product Intake

Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake

Oxidative Stress After 12 Weeks of Product Intake

Overall Study

Prof. Stephen Atkin, Principal Investigator

Diabetes Type 2

20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given

Cocoa Polyphenols

Endocrinology, Diabetes & Metabolism, Hull York Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road

A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial

Nestlé

Arterial Hypertension

Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids

Dark chocolate

Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids

White chocolate

Sede Investigaciones Universitarias, Universidad de Antioquia

Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension

Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring

Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring

Monica Lucia Giraldo

Universidad de Antioquia

Cardiovascular Health

placebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit

flavanol/mŕtvica

Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery

COcoa Supplement and Multivitamin Outcomes Study

A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial

Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health

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