Table 1.
Basic characteristics of men at baseline by randomization group
| Participant Characteristics | Fish Oil (n = 29) |
Green Tea (n = 15) |
Fish Oil + Green Tea (n=14) |
Placebo (n = 28) |
p1, 2, 3 |
|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||
| Age,yr | 63.3 (5.0) | 64.5 (7.2) | 62.6 (7.5) | 61.8 (6.4) | 0.57 |
| BMI (kg/m2) at baseline | 28.5 (5.0) | 30.1 (3.7) | 29.0 (4.0) | 28.1 (4.1) | 0.54 |
| Prostate Specific Antigen (PSA) Pre- intervention |
6.5 (4.2) | 6.9 (2.6) | 4.8 (2.5) | 6.9 (4.2) | 0.34 |
| Prostate Specific Antigen (PSA) Post-intervention |
6.0 (4.2) | 6.4 (3.3) | 10.8 (18.3) | 7.1 (6.1) | 0.38 |
| FAS H-score Pre-intervention | 138.3 (63.8) | 158.8 (84.6) | 142.7 (102.8) | 114.2 (85.4) | 0.22 |
| FAS H-score Post- intervention | 145.2 (72.2) | 159.3 (75.5) | 140.7 (100.3) | 157.3 (81.5) | 0.79 |
| Ki-67 number of positive cells per high power field Pre-intervention |
13.5 (10.3) | 18.3 (15.9) | 17.9 (12.1) | 15.7 (13.6) | 0.68 |
| Ki-67 number of positive cells per high power field Post- intervention |
11.8 (7.9) | 7.9 (6.6) | 21.8 (17.2) | 13.1 (9.6) | 0.05 |
| n (%) | n (%) | n (%) | n (%) | ||
| Race | 0.45 | ||||
| White | 28 (96.6) | 13 (86.7) | 14 (100.0) | 27 (96.4) | |
| Non-White | 1 (3.4) | 2 (13.3) | 0 (0.00) | 1 (3.6) | |
| Marital status | 0.34 | ||||
| Single, Divorced, Widowed | 3 (10.3) | 3 (20.0) | 0 (0.0) | 4 (10.7) | |
| Married/partner | 26 (89.7) | 11 (73.3) | 14 (100.0) | 21 (75.0) | |
| Missing | 0 (0.0) | 1 (6.7) | 0 (0.0) | 3 (14.3) | |
| Income | 0.74 | ||||
| ≤$50,000 | 5 (17.3) | 3 (20.0) | 1 (7.1) | 2 (7.1) | |
| >$50,000 | 13 (44.8) | 5 (33.3) | 4 (28.6) | 11 (39.3) | |
| Refuse/Don’t know/missing | 11 (37.9) | 7 (46.7) | 9 (64.3) | 15 (53.6) | |
| Education | 0.70 | ||||
| ≤ Some college/technical | 6 (20.7) | 3 (20.0) | 3 (21.4) | 3 (10.7) | |
| ≥ College graduate | 8 (27.6) | 6 (40.0) | 5 (35.7) | 11 (39.3) | |
| Missing | 15 (51.7) | 6 40.0) | 6 (42.9) | 14 (50.0) | |
| Smoking | 0.10 | ||||
| Current | 5 (17.2) | 0 (0.0) | 2 (14.3) | 6 (21.4) | |
| Former | 14 (48.3) | 11 (73.3) | 7 (50.0) | 7 (25.0) | |
| Never | 9 (31.0) | 2 (13.3) | 3 (21.4) | 10 (35.7) | |
| Missing | 1 (3.5) | 2 (13.3) | 2 (14.3) | 5 (17.9) | |
| Alcohol | 0.13 | ||||
| Current | 14 (48.3) | 5 (33.3) | 3 (21.4) | 17 (60.7) | |
| Former | 7 (24.1) | 6 (40.0) | 8 (57.1) | 6 (21.4) | |
| Never | 7 (24.1) | 3 (20.0) | 3 (21.4) | 2 (7.1) | |
| Missing | 1 (3.5) | 1 (6.7) | 0 (7.1) | 3 (10.7) | |
| Family history of Cancer | 0.52 | ||||
| Yes | 9 (31.0) | 2 (13.3) | 5 (35.7) | 7 (25.0) | |
| No | 20 (69.0) | 13 (86.7) | 9 (64.3) | 21 (75.0) | |
| Use of NSAIDs | 0.76 | ||||
| Yes | 17 (58.6) | 6 (40.0) | 7 (50.0) | 14 (50.0) | |
| No | 10 (34.5) | 7 (46.7) | 6 (42.9) | 9 (32.1) | |
| Missing | 2 (6.9) | 2 (13.3) | 1 (7.1) | 5 (17.9) | |
| Repeat Pathology Biopsy Diagnosis4 | 0.41 | ||||
| Benign | 16 (55.2) | 11 (73.3) | 9 (64.3) | 18 (64.3) | |
| Malignant | 6 (20.7) | 1 (6.7) | 2 (14.3) | 6 (21.4) | |
| Prostatic Intraepithelial Neoplasia (PIN) |
6 (20.7) | 3 (20.0) | 3 (21.4) | 1 (3.6) | |
| Missing | 1 (3.4) | 0 (0.0) | 0 (0.0) | 3 (10.7) | |
One-way analysis of variance (ANOVA) tests were conducted for continuous variables (age, BMI, PSA); Kruskal–Wallis test was used for comparing variables without normal distribution (FAS H-score and Ki-67 % positivity), chi-square tests were conducted for categorical variables with expected cell frequencies ≥ 5 (Use of NSAIDs); and Fisher-Freeman-Halton tests were conducted for categorical variables with expected cell frequencies < 5.
p-value ANOVA or chi-square tests between supplement and placebo groups, *p <0.05. All the p-values were calculated excluding missing category.
Percentages may not add up to 100 due to rounding values.
All the baseline biopsies were diagnosed as benign (n=61, 71%) or PIN (n=25, 29%).