Table 1.

Characteristics of intervention group participants in the PPT by adenoma recurrence at the end of year 4 (n = 872)

CharacteristicsAdenoma recurrence (T4)
NoAdvancedHigh-riskAny
Median (IQR) or %*Median (IQR) or %*PMedian (IQR) or %*PMedian (IQR) or %*P
Sample size52449100348
Baseline (T0)
    Gender (% male)64690.53760.02700.05
    Race (% Caucasian)88860.64900.73900.58
    Education (% ≤high school)22310.21310.07270.11
    Family history of colorectal cancer (% yes)27271.00300.46260.88
    Smoker (% current)*11140.48180.07140.21
    NSAID use (% yes)35310.54330.65370.67
    Supplement use (% yes)45370.30380.23430.68
    Hormone therapy (% yes)1380.3860.0490.05
    Age (y)60.0 (52.0-67.0)66.0 (60.0-71.0)0.000666.0 (58.0-71.0)<0.000164.0 (57.0-70.0)<0.0001
    BMI (kg/m2)27.5 (24.8-30.3)28.6 (26.1-32.4)0.0128.3 (25.4-31.1)0.0627.6 (25.1-30.6)0.36
    Physical activity (h/wk)§8.50 (4.00-15.1)7.16 (2.67-12.0)0.198.27 (3.33-13.1)0.218.46 (3.82-16.0)0.93
    Dietary intake
        Alcohol (g/d)0.92 (0.00-9.78)0.61 (0.00-2.10)0.160.85 (0.00-8.61)0.910.85 (0.00-10.3)0.93
        Energy (1,000 kcal/d)1.84 (1.51-2.19)1.83 (1.51-2.27)0.911.85 (1.57-2.27)0.401.89 (1.55-2.29)0.10
        Fat (% kcal/d)35.6 (30.1-40.3)35.8 (31.1-40.5)0.5735.4 (30.6-40.2)0.9835.6 (30.0-40.7)0.89
        Fat (g/d)64.0 (49.1-79.8)67.7 (46.8-81.1)0.7167.6 (49.1-81.9)0.5067.6 (49.4-83.5)0.18
        Fiber (g/d)16.8 (12.9-22.9)16.3 (13.2-23.8)0.9817.4 (13.4-23.1)0.9017.6 (13.5-22.6)0.64
        Fruits and vegetables (serv./d)3.44 (2.56-4.67)3.53 (2.54-4.59)0.983.58 (2.55-4.74)0.723.63 (2.61-4.91)0.07
        Flavonols (mg/d)14.1 (9.40-20.8)12.2 (7.83-18.1)0.1113.8 (8.65-19.9)0.5115.5 (10.1-22.8)0.05
            Isorhamnetin (mg/d)0.24 (0.10-0.51)0.19 (0.10-0.51)0.490.22 (0.12-0.53)0.980.25 (0.13-0.60)0.06
            Kaempferol (mg/d)4.74 (2.54-8.04)3.99 (1.98-5.19)0.074.15 (1.98-7.26)0.364.91 (2.70-9.38)0.18
            Myricetin (mg/d)0.83 (0.51-1.44)0.87 (0.53-1.34)0.940.82 (0.45-1.36)0.520.90 (0.51-1.52)0.38
            Quercetin (mg/d)7.48 (5.01-11.3)6.67 (4.46-10.9)0.337.43 (4.49-11.5)0.678.11 (5.40-11.6)0.11
        Dry beans (g/d)7.54 (3.27-11.3)4.90 (3.27-11.3)0.257.00 (1.63-11.3)0.447.54 (3.27-14.0)0.29
        Other vegetables (g/d)16.8 (3.80-47.0)12.8 (2.92-45.9)0.6616.3 (4.45-48.1)0.7321.7 (5.84-55.8)0.04
        Tea (g/d)0.00 (0.00-72.0)0.00 (0.00-38.6)0.490.00 (0.00-32.1)0.405.93 (0.00-72.0)0.46
        Apples (g/d)18.8 (4.61-48.1)19.7 (4.61-39.4)0.8818.4 (4.63-39.4)0.8116.6 (6.67-39.4)0.71
    Serologic measures (in pg/mL)
        IL-61.89 (1.36-2.81)1.77 (1.40-2.62)0.942.04 (1.45-2.75)0.191.91 (1.36-2.92)0.78
Intervention (T1,2,3):
    NSAID use (% yes)22201.00220.90230.62
    Supplement use (% yes)35290.35280.17290.07
    Hormone therapy (% yes)1180.6460.1570.08
    BMI (kg/m2)26.8 (24.3-29.6)28.8 (25.6-32.2)0.00427.9 (25.2-30.6)0.0127.3 (24.6-30.0)0.18
    Physical activity (h/wk)§7.84 (4.19-13.3)5.13 (2.89-8.25)0.0026.92 (4.02-11.5)0.117.51 (4.14-13.5)0.42
    Dietary intake
        Alcohol (g/d)0.90 (0.00-8.76)0.98 (0.00-4.93)0.240.98 (0.00-5.63)0.420.96 (0.00-8.26)0.51
        Energy (1,000 kcal/d)1.78 (1.52-2.09)1.82 (1.60-1.99)0.951.80 (1.56-1.99)0.921.79 (1.54-2.07)1.00
        Fat (% kcal/d)22.4 (18.5-26.6)27.4 (22.2-30.6)0.000225.1 (20.9-30.0)0.000322.9 (19.7-28.1)0.03
        Fat (g/d)38.9 (31.2-50.0)47.1 (38.1-55.2)0.00444.2 (36.8-52.8)0.00441.3 (32.8-51.4)0.10
        Fiber (g/d)32.1 (24.0-40.8)29.4 (21.5-37.7)0.0829.4 (21.6-36.2)0.0130.9 (22.8-39.0)0.13
        Fruits and vegetables (serv./d)5.72 (4.43-7.15)4.98 (4.06-6.03)0.015.24 (4.36-6.56)0.035.65 (4.48-6.99)0.54
        Flavonols (mg/d)29.7 (21.4-40.8)21.0 (15.0-30.1)0.000225.4 (16.2-36.1)0.00529.7 (21.0-38.9)0.59
            Isorhamnetin (mg/d)0.73 (0.42-1.10)0.59 (0.30-0.89)0.020.61 (0.29-0.98)0.010.73 (0.44-1.12)0.89
            Kaempferol (mg/d)13.9 (7.83-21.5)8.27 (5.19-14.4)0.000210.9 (5.40-18.5)0.0113.6 (7.89-20.9)0.40
            Myricetin (mg/d)0.99 (0.68-1.63)0.91 (0.62-1.49)0.180.89 (0.56-1.57)0.061.06 (0.65-1.68)1.00
            Quercetin (mg/d)13.3 (9.70-16.8)11.1 (7.55-14.7)0.00712.1 (8.01-15.0)0.0113.3 (9.58-16.6)0.98
        Dry beans (g/d)31.2 (15.3-54.6)14.0 (7.37-35.2)0.000123.0 (8.79-42.1)0.00530.3 (14.4-49.5)0.26
        Other vegetables (g/d)72.3 (37.7-110)51.5 (23.5-89.5)0.0157.5 (22.3-97.7)0.0171.4 (42.6-109)0.88
        Tea (g/d)11.9 (0.00-72.0)3.96 (0.00-48.9)0.193.96 (0.00-55.2)0.169.23 (0.00-91.3)0.49
        Apples (g/d)57.6 (29.3-89.7)45.3 (19.7-61.4)0.0353.0 (23.9-82.3)0.3353.5 (29.2-88.5)0.79
    Serologic measures (in pg/mL):
        IL-6 (T1)1.89 (1.29-2.72)2.03 (1.64-2.86)0.122.27 (1.63-3.19)0.0021.92 (1.38-2.90)0.17
        IL-6 (T3)2.03 (1.40-3.07)2.21 (1.65-3.20)0.312.44 (1.71-3.50)0.012.05 (1.55-2.94)0.37
        IL-6 (T1,3)1.96 (1.43-2.77)2.11 (1.66-3.07)0.122.33 (1.68-3.26)0.0022.05 (1.54-2.90)0.21
        IL-6 (T1-T0)−0.06 (−0.56-0.39)0.27 (−0.20-0.66)0.020.12 (−0.29-0.70)0.040.05 (−0.41-0.57)0.05
        IL-6 (T3-T0)0.07 (−0.54-0.67)0.23 (−0.19-0.80)0.210.24 (−0.27-0.91)0.190.16 (−0.42-0.76)0.34
        IL-6 (T1,3-T0)0.03 (−0.50-0.51)0.29 (−0.13-0.61)0.060.25 (−0.23-0.82)0.040.10 (−0.33-0.58)0.07

Abbreviations: IQR, interquartile range. NSAID, nonsteroidal anti-inflammatory drug; BMI, body mass index.

  • *Family history of colorectal cancer was defined as having ≥1 first-degree relative with colorectal cancer at baseline.

  • 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.

  • 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 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 included 30% white onions, 5% red onions, 27% cucumbers, 16% celery, 12% radishes, and 10% pepper.

  • T1,2,3: mean values of the first 3 y of the trial. T1,3 = geometric mean of year 1 and year 3 values. T1,3-T0 = T1,3 minus baseline values.