TABLE 1.
Characteristics of the participants at baseline, according to randomized assignment1
| Total (n = 21,442) | Cocoa extract (n = 10,719) | Placebo (n = 10,723) | ||||
|---|---|---|---|---|---|---|
| n | (%) | n | (%) | n | (%) | |
| Female sex | 12,666 | (59.1) | 6337 | (59.1) | 6329 | (59.0) |
| Age, mean ± SD, y | 72.1 ± 6.6 | 72.1 ± 6.6 | 72.1 ± 6.6 | |||
| Hispanic/Latino2 | 544 | (2.6) | 252 | (2.5) | 292 | (2.8) |
| Race/ethnicity2 | ||||||
| White | 19,294 | (90.0) | 9624 | (89.8) | 9670 | (90.2) |
| African American | 1131 | (5.3) | 558 | (5.2) | 573 | (5.3) |
| Asian/Pacific Islander | 499 | (2.3) | 274 | (2.6) | 225 | (2.1) |
| American Indian/Alaska Native | 59 | (0.3) | 31 | (0.3) | 28 | (0.3) |
| Multiracial/other/unknown or not reported | 459 | (2.1) | 232 | (2.2) | 227 | (2.1) |
| Education | ||||||
| High school diploma/GED or less | 2296 | (10.8) | 1141 | (10.7) | 1155 | (10.9) |
| Attended or graduated from college | 8685 | (40.9) | 4328 | (40.8) | 4357 | (41.1) |
| Post-college | 10,241 | (48.3) | 5147 | (48.5) | 5094 | (48.0) |
| Smoking status | ||||||
| Never | 11,565 | (54.7) | 5766 | (54.6) | 5799 | (54.9) |
| Past | 8731 | (41.3) | 4396 | (41.6) | 4335 | (41.0) |
| Current | 835 | (4.0) | 398 | (3.8) | 437 | (4.1) |
| Cocoa extract use before run-in | 91 | (0.4) | 45 | (0.4) | 46 | (0.4) |
| Chocolate consumption | ||||||
| Monthly or less | 6275 | (31.8) | 3095 | (31.5) | 3180 | (32.2) |
| Weekly or daily | 13,446 | (68.2) | 6740 | (68.5) | 6706 | (67.8) |
| History of diabetes | 2864 | (13.4) | 1417 | (13.2) | 1447 | (13.5) |
| History of high blood pressure | 12,423 | (58.1) | 6190 | (57.9) | 6233 | (58.3) |
| Statin use | 8911 | (42.1) | 4480 | (42.3) | 4431 | (41.9) |
| Aspirin use | 10,379 | (48.9) | 5211 | (49.1) | 5168 | (48.7) |
| No. of cardiovascular risk factors3 | ||||||
| 0–1 | 9159 | (42.9) | 4561 | (42.7) | 4598 | (43.1) |
| 2 | 6289 | (29.5) | 3167 | (29.7) | 3122 | (29.3) |
| ≥3 | 5901 | (27.6) | 2950 | (27.6) | 2951 | (27.7) |
| History of cardiovascular disease4 | 1269 | (6.0) | 626 | (5.9) | 643 | (6.1) |
| History of revascularization (CABG/PCI) | 862 | (4.0) | 430 | (4.0) | 432 | (4.0) |
| History of unstable angina | 374 | (1.8) | 170 | (1.6) | 204 | (1.9) |
| History of carotid artery surgery/stenting | 93 | (0.4) | 47 | (0.4) | 46 | (0.4) |
| History of peripheral artery surgery/stenting | 144 | (0.7) | 75 | (0.7) | 69 | (0.7) |
| History of heart failure | 364 | (1.7) | 173 | (1.6) | 191 | (1.8) |
| History of cancer excluding non-melanoma skin cancer | 3550 | (16.6) | 1775 | (16.6) | 1775 | (16.6) |
n = 21,442. Percentages may not sum to 100 because of rounding. Data on age and sex were complete. Data on other characteristics, except for chocolate consumption, were available for ≥98.0% of the trial participants. Chocolate consumption was missing for 8.0% [n = 1721; 8.2% (n = 884) vs. 7.8% (n = 837)] of participants. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; GED, General Educational Development.
Ethnic group and race were self-reported by participants. Multiracial participants self-identified with >1 race. Participants of other race or unknown race self-identified with those categories.
Cardiovascular risk factors were history of hypertension, diabetes, taking cholesterol-lowering medication, smoking (ever), and parental history of early myocardial infarction (<65 y).
Defined as history at baseline of CABG/PCI, unstable angina, carotid artery surgery/stenting, or peripheral artery surgery/stenting.