Table 1.
Characteristics of intervention group participants in the Polyp Prevention Trial by adenoma recurrence at the end of year 4 (n = 872)
| Adenoma Recurrence (T4) |
|||||||
|---|---|---|---|---|---|---|---|
| No | Advanced | High Risk | Any | ||||
| Characteristics | Median (IQR)† | Median (IQR)† | P value* | Median (IQR)† | P value* | Median (IQR)† | P value* |
| Sample size | 524 | 49 | 100 | 348 | |||
| Baseline (T0): | |||||||
| Gender (% male) | 64 | 69 | 0.53 | 76 | 0.02 | 70 | 0.05 |
| Race (% Caucasian) | 88 | 86 | 0.64 | 90 | 0.73 | 90 | 0.58 |
| Education (% ≤ high school) | 22 | 31 | 0.21 | 31 | 0.07 | 27 | 0.11 |
| Family history of colorectal | 27 | 27 | 1.00 | 30 | 0.46 | 26 | 0.88 |
| Smoker (% current)† | 11 | 14 | 0.48 | 18 | 0.07 | 14 | 0.21 |
| NSAID use (% yes)‡ | 35 | 31 | 0.54 | 33 | 0.65 | 37 | 0.67 |
| Supplement use (%yes)‡ | 45 | 37 | 0.30 | 38 | 0.23 | 43 | 0.68 |
| Hormone therapy (% yes)‡ | 13 | 8 | 0.38 | 6 | 0.04 | 9 | 0.05 |
| Age (y) | 60.0 (52.0–67.0) | 66.0 (60.0–71.0) | 0.0006 | 66.0 (58.0–71.0) | <.0001 | 64.0 (57.0–70.0) | <.0001 |
| Body mass index (kg/m2) | 27.5 (24.8–30.3) | 28.6 (26.1–32.4) | 0.01 | 28.3 (25.4–31.1) | 0.06 | 27.6 (25.1–30.6) | 0.36 |
| Physical activity (hr/wk)§ | 8.50 (4.00–15.1) | 7.16 (2.67–12.0) | 0.19 | 8.27 (3.33–13.1) | 0.21 | 8.46 (3.82–16.0) | 0.93 |
| Dietary intake: | |||||||
| Alcohol (g/d) | 0.92 (0.00–9.78) | 0.61 (0.00–2.10) | 0.16 | 0.85 (0.00–8.61) | 0.91 | 0.85 (0.00–10.3) | 0.93 |
| Energy (1,000 kcal/d) | 1.84 (1.51–2.19) | 1.83 (1.51–2.27) | 0.91 | 1.85 (1.57–2.27) | 0.40 | 1.89 (1.55–2.29) | 0.10 |
| Fat (% kcal/d) | 35.6 (30.1–40.3) | 35.8 (31.1–40.5) | 0.57 | 35.4 (30.6–40.2) | 0.98 | 35.6 (30.0–40.7) | 0.89 |
| Fat (g/d) | 64.0 (49.1–79.8) | 67.7 (46.8–81.1) | 0.71 | 67.6 (49.1–81.9) | 0.50 | 67.6 (49.4–83.5) | 0.18 |
| Fiber (g/d) | 16.8 (12.9–22.9) | 16.3 (13.2–23.8) | 0.98 | 17.4 (13.4–23.1) | 0.90 | 17.6 (13.5–22.6) | 0.64 |
| Fruits & vegetables (serv./d) | 3.44 (2.56–4.67) | 3.53 (2.54–4.59) | 0.98 | 3.58 (2.55–4.74) | 0.72 | 3.63 (2.61–4.91) | 0.07 |
| Flavonols (mg/d) | 14.1 (9.40–20.8) | 12.2 (7.83–18.1) | 0.11 | 13.8 (8.65–19.9) | 0.51 | 15.5 (10.1–22.8) | 0.05 |
| Isorhamnetin (mg/d) | 0.24 (0.10–0.51) | 0.19 (0.10–0.51) | 0.49 | 0.22 (0.12–0.53) | 0.98 | 0.25 (0.13–0.60) | 0.06 |
| Kaempferol (mg/d) | 4.74 (2.54–8.04) | 3.99 (1.98–5.19) | 0.07 | 4.15 (1.98–7.26) | 0.36 | 4.91 (2.70–9.38) | 0.18 |
| Myricetin (mg/d) | 0.83 (0.51–1.44) | 0.87 (0.53–1.34) | 0.94 | 0.82 (0.45–1.36) | 0.52 | 0.90 (0.51–1.52) | 0.38 |
| Quercetin (mg/d) | 7.48 (5.01–11.3) | 6.67 (4.46–10.9) | 0.33 | 7.43 (4.49–11.5) | 0.67 | 8.11 (5.40–11.6) | 0.11 |
| Dry beans (g/d) | 7.54 (3.27–11.3) | 4.90 (3.27–11.3) | 0.25 | 7.00 (1.63–11.3) | 0.44 | 7.54 (3.27–14.0) | 0.29 |
| Other vegetables (g/d)∥ | 16.8 (3.80–47.0) | 12.8 (2.92–45.9) | 0.66 | 16.3 (4.45–48.1) | 0.73 | 21.7 (5.84–55.8) | 0.04 |
| Tea (g/d) | 0.00 (0.00–72.0) | 0.00 (0.00–38.6) | 0.49 | 0.00 (0.00–32.1) | 0.40 | 5.93 (0.00–72.0) | 0.46 |
| Apples (g/d) | 18.8 (4.61–48.1) | 19.7 (4.61–39.4) | 0.88 | 18.4 (4.63–39.4) | 0.81 | 16.6 (6.67–39.4) | 0.71 |
| Serological measures (in pg/mL): | |||||||
| Interleukin-6 | 1.89 (1.36–2.81) | 1.77 (1.40–2.62) | 0.94 | 2.04 (1.45–2.75) | 0.19 | 1.91 (1.36–2.92) | 0.78 |
| Intervention (T1,2,3 ** ): | |||||||
| NSAID use (% yes)‡ | 22 | 20 | 1.00 | 22 | 0.90 | 23 | 0.62 |
| Supplement use (% yes)‡ | 35 | 29 | 0.35 | 28 | 0.17 | 29 | 0.07 |
| Hormone therapy (% yes)‡ | 11 | 8 | 0.64 | 6 | 0.15 | 7 | 0.08 |
| Body mass index (kg/m2) | 26.8 (24.3–29.6) | 28.8 (25.6–32.2) | 0.004 | 27.9 (25.2–30.6) | 0.01 | 27.3 (24.6–30.0) | 0.18 |
| Physical activity (hr/wk)§ | 7.84 (4.19–13.3) | 5.13 (2.89–8.25) | 0.002 | 6.92 (4.02–11.5) | 0.11 | 7.51 (4.14–13.5) | 0.42 |
| Dietary intake: | |||||||
| Alcohol (g/d) | 0.90 (0.00–8.76) | 0.98 (0.00–4.93) | 0.24 | 0.98 (0.00–5.63) | 0.42 | 0.96 (0.00–8.26) | 0.51 |
| Energy (1,000 kcal/d) | 1.78 (1.52–2.09) | 1.82 (1.60–1.99) | 0.95 | 1.80 (1.56–1.99) | 0.92 | 1.79 (1.54–2.07) | 1.00 |
| Fat (% kcal/d) | 22.4 (18.5–26.6) | 27.4 (22.2–30.6) | 0.0002 | 25.1 (20.9–30.0) | 0.0003 | 22.9 (19.7–28.1) | 0.03 |
| Fat (g/d) | 38.9 (31.2–50.0) | 47.1 (38.1–55.2) | 0.004 | 44.2 (36.8–52.8) | 0.004 | 41.3 (32.8–51.4) | 0.10 |
| Fiber (g/d) | 32.1 (24.0–40.8) | 29.4 (21.5–37.7) | 0.08 | 29.4 (21.6–36.2) | 0.01 | 30.9 (22.8–39.0) | 0.13 |
| Fruits & vegetables (serv./d) | 5.72 (4.43–7.15) | 4.98 (4.06–6.03) | 0.01 | 5.24 (4.36–6.56) | 0.03 | 5.65 (4.48–6.99) | 0.54 |
| Flavonols (mg/d) | 29.7 (21.4–40.8) | 21.0 (15.0–30.1) | 0.0002 | 25.4 (16.2–36.1) | 0.005 | 29.7 (21.0–38.9) | 0.59 |
| Isorhamnetin (mg/d) | 0.73 (0.42–1.10) | 0.59 (0.30–0.89) | 0.02 | 0.61 (0.29–0.98) | 0.01 | 0.73 (0.44–1.12) | 0.89 |
| Kaempferol (mg/d) | 13.9 (7.83–21.5) | 8.27 (5.19–14.4) | 0.0002 | 10.9 (5.40–18.5) | 0.01 | 13.6 (7.89–20.9) | 0.40 |
| Myricetin (mg/d) | 0.99 (0.68–1.63) | 0.91 (0.62–1.49) | 0.18 | 0.89 (0.56–1.57) | 0.06 | 1.06 (0.65–1.68) | 1.00 |
| Quercetin (mg/d) | 13.3 (9.70–16.8) | 11.1 (7.55–14.7) | 0.007 | 12.1 (8.01–15.0) | 0.01 | 13.3 (9.58–16.6) | 0.98 |
| Dry beans (g/d) | 31.2 (15.3–54.6) | 14.0 (7.37–35.2) | 0.0001 | 23.0 (8.79–42.1) | 0.005 | 30.3 (14.4–49.5) | 0.26 |
| Other vegetables (g/d)∥ | 72.3 (37.7–110) | 51.5 (23.5–89.5) | 0.01 | 57.5 (22.3–97.7) | 0.01 | 53.5 (29.2–88.5) | 0.88 |
| Tea (g/d) | 11.9 (0.00–72.0) | 3.96 (0.00–48.9) | 0.19 | 0.00 (0.00–55.2) | 0.16 | 9.23 (0.00–40.7) | 0.49 |
| Apples (g/d) | 57.6 (29.3–89.7) | 45.3 (19.7–61.4) | 0.03 | 53.0 (23.9–82.3) | 0.33 | 53.5 (29.2–88.5) | 0.79 |
| Serological measures (in pg/mL): | |||||||
| Interleukin-6 (T1) | 1.89 (1.29–2.72) | 2.03 (1.64–2.86) | 0.12 | 2.27 (1.63–3.19) | 0.002 | 1.92 (1.38–2.90) | 0.17 |
| Interleukin-6 (T3) | 2.03 (1.40–3.07) | 2.21 (1.65–3.20) | 0.31 | 2.44 (1.71–3.50) | 0.01 | 2.05 (1.55–2.94) | 0.37 |
| Interleukin-6 (T1,3**) | 1.96 (1.43–2.77) | 2.11 (1.66–3.07) | 0.12 | 2.33 (1.68–3.26) | 0.002 | 2.05 (1.54–2.90) | 0.21 |
| Interleukin-6 (T1–T0) | −.06 (−.56–0.39) | 0.27 (−.20–0.66) | 0.02 | 0.12 (−.29–0.70) | 0.04 | 0.05 (−.41–0.57) | 0.05 |
| Interleukin-6 (T3–T0) | 0.07 (−.54–0.67) | 0.23 (−.19–0.80) | 0.21 | 0.24 (−.27–0.91) | 0.19 | 0.16 (−.42–0.76) | 0.34 |
| Interleukin-6 (T1,3–T0**) | 0.03 (−.50–0.51) | 0.29 (−.13–0.61) | 0.06 | 0.25 (−.23–0.82) | 0.04 | 0.10 (−.33–0.58) | 0.07 |
*
All comparisons against the no adenoma recurrence group. P values for differences in proportions were calculated using Fisher's exact test. P values for differences in medians were calculated using Wilcoxon rank-sum test.
†
Family history of colorectal cancer was defined as having ≥ 1 first-degree relative with colorectal cancer at baseline.
‡
Regular dietary supplement use was defined as taking supplement ≥ 1 weekly. Regular medication use, including NSAIDs, was defined as taking medication ≥ 1 monthly. Hormone replacement therapy included both unopposed estrogen and estrogen/progestin combinations.
§
Physical activity was defined as self-reported time typically spent for any type of moderate or vigorous physical activity.
∥
Other vegetables (30% white onions, 5% red onions, 27% cucumbers, 16% celery, 12% radishes, and 10% pepper).
**
T1,2,3: mean values of the first three years of the trial. T1,3 = geometric mean of year 1 and 3 values. T1,3–T0 = T1,3 minus baseline values.