Table 5.
Baseline Demographic and Clinical Characteristics of all Randomized Participants; ITT Model, Minnesota, 2009–2014 (n= 1075)
| GTE (n= 538) | Placebo (n= 537) | p valuea | |
|---|---|---|---|
| Age at baseline, y | 59.9 (5.0) | 59.6 (5.1) | 0.35 |
| Race | 0.44 | ||
| - White | 515 (95.7) | 505 (94.0) | |
| - Asian | 3 (0.6) | 7 (1.3) | |
| - Black | 4 (0.7) | 7 (1.3) | |
| - Others | 4 (0.7) | 2 (0.4) | |
| - Unknown | 12 (2.2) | 16 (3.0) | |
| Ethnicity | 0.76 | ||
| - Hispanic | 5 (0.9) | 6 (1.1) | |
| - Non-Hispanic | 516 (95.9) | 510 (95.0) | |
| - Unknown | 17 (3.2) | 21 (3.9) | |
| COMT genotype | 0.51 | ||
| - High | 144 (26.8) | 141 (26.3) | |
| - Intermediate | 216 (40.2) | 233 (43.4) | |
| - Low | 178 (33.1) | 163 (30.3) | |
| Level of education | 0.19 | ||
| - High school or less | 33 (6.1) | 39 (7.3) | |
| - Some college | 348 (64.7) | 313 (58.3) | |
| - Postgraduate or professional degree | 143 (26.6) | 166 (30.9) | |
| - Unknown | 14 (2.6) | 19 (3.5) | |
| Family history of breast cancerb | 0.71 | ||
| - No | 384 (71.4) | 394 (73.4) | |
| - Yes | 130 (24.2) | 123 (22.9) | |
| - Unknown | 24 (4.5) | 20 (3.7) | |
| Age at menarche, yc | 13.0 (1.4) | 13.0 (1.4) | 0.97 |
| Parity Status | 0.46 | ||
| - Nulliparous | 118 (21.9) | 125 (23.3) | |
| - Parous | 407 (75.7) | 393 (73.2) | |
| - Unknown | 13 (2.4) | 19 (3.5) | |
| Age at first live birth, yd,e | 27.8 (5.4) | 28.4 (5.5) | 0.16 |
| Breastfeeding, total monthsd,f | 13.0 (16.7) | 12.9 (15.8) | 0.96 |
| Type of menopause | 0.11 | ||
| - Natural | 448 (83.3) | 445 (82.9) | |
| - Surgical: bilateral oophorectomy | 41 (7.6) | 54 (10.1) | |
| - Surgical: ovarian status unknown | 32 (6.0) | 18 (3.4) | |
| - Unknown | 17 (3.2) | 20 (3.7) | |
| Age at menopause, yg | 49.0 (5.8) | 49.2 (5.3) | 0.53 |
| Years since menopauseh | 10.9 (7.8) | 10.3 (7.2) | 0.20 |
| Past use of oral contraceptives | 0.70 | ||
| - No | 68 (12.6) | 77 (14.3) | |
| - Yes | 455 (84.6) | 444 (82.7) | |
| - Unknown | 15 (2.8) | 16 (3.0) | |
| Past use of hormone therapy | 0.87 | ||
| - No | 306 (56.9) | 302 (56.2) | |
| - Yes | 216 (40.2) | 216 (40.2) | |
| - Unknown | 16 (3.0) | 19 (3.5) | |
| Height, cmi | 163.5 (6.3) | 164.3 (6.2) | 0.04 |
| Weight, kgi | 67.4 (10.6) | 67.9 (10.5) | 0.41 |
| BMI, kg/m2 i | 25.2 (3.7) | 25.2 (3.9) | 0.91 |
| Waist-to-hip ratioj | 0.84 (0.1) | 0.83 (0.1) | 0.26 |
| Use of vitamin supplements | 0.03 | ||
| - No | 48 (8.9) | 76 (14.2) | |
| - Yes | 477 (88.7) | 447 (83.2) | |
| - Unknown | 13 (2.4) | 14 (2.6) | |
| Smoking status | 0.98 | ||
| - Never | 357 (66.4) | 356 (66.3) | |
| - Former | 167 (31.0) | 166 (30.9) | |
| - Unknown | 14 (2.6) | 15 (2.8) | |
| Alcohol drinks/week (drinkers only)k | 3.3 (3.0) | 3.4 (3.0) | 0.77 |
| Self-reported physical activity, MET-h/weekl | 45.3 (53.1) | 51.4 (104.0) | 0.23 |
Abbreviations: ITT, intention-to-treat; GTE, green tea extract; BMI, body mass index; COMT, catechol-O-methyltransferase; MET, metabolic equivalent.
NOTE: Data presented as the means (SD) for continuous variables and as frequencies (%) for categorical variables.
p value for difference between the randomized GTE with the randomized Placebo participants.
Only in first degree relatives.
GTE (n)= 519; Placebo (n)= 509.
Among parous women only.
GTE (n)= 407; Placebo (n)= 393.
GTE (n)= 401; Placebo (n)= 386.
GTE (n)= 500; Placebo (n)= 501.
GTE (n)= 498; Placebo (n)= 501.
GTE (n)= 526; Placebo (n)= 523.
GTE (n)= 524; Placebo (n)= 523.
Only among alcohol drinkers; GTE (n)= 418; Placebo (n)= 434.