Variable | Treatment group | P value** | |
---|---|---|---|
Flaxseed | Placebo | ||
Mean (SD) | Mean (SD) | ||
Global constipation symptom scores | |||
Baseline | −1.38 (0.8) | −1.00 (1.4) | 0.627 |
After 4 week therapy | −1.77 (1.5) | − 1.74 (0.8) | 0.257 |
After 8 week therapy | −0.50 (1.7) | −1.76 (0.8) | 0.016 |
After 12 week therapy | 1.08 (1.4) | −0.59 (1.4) | 0.003 |
P value* | < 0.001 | 0.003 | – |
Change from baseline | 2.46 | 0.41 | 0.008 |
After 4 week without therapy | −0.42 (1.6) | −0.81 (1.5) | 0.257 |
Bristol Stool Form Scale | |||
Baseline | 1.35 (0.5) | 1.26 (0.5) | 0.975 |
After 4 week therapy | 2.38 (0.6) | 1.59 (1.2) | 0.026 |
After 8 week therapy | 2.96 (0.6) | 1.33 (0.6) | < 0.001 |
After 12 week therapy | 3.31 (0.7) | 1.85 (1.6) | 0.005 |
P value* | < 0.001 | 0.307 | – |
Change from baseline | 1.96 | 0.59 | 0.005 |
After 4 week without therapy | 1.92 (0.8) | 1.44 (0.8) | 0.057 |
Weight (kg) | |||
Baseline | 75.4 (10.6) | 73.1 (12.0) | 0.578 |
After 12 week therapy | 71.6 (8.8) | 73.1 (11.3) | 0.749 |
P value* | < 0.001 | 0.947 | – |
Change from baseline | −3.8 | 0.0 | < 0.001 |
Body mass index (kg/m2) | |||
Baseline* | 29.1 (3.8) | 28.7 (5.9) | 0.976 |
After 12 week therapy | 27.6 (3.1) | 28.6 (5.6) | 0.375 |
P value | < 0.001 | 0.930 | – |
Change from baseline | −1.5 | −0.1 | < 0.001 |
FPG (mg/dl) | |||
Baseline | 164.8 (45.2) | 165.6 (43.5) | 0.980 |
After 4 week therapy | 163.8 (45.1) | 166.0 (42.5) | 0.914 |
After 8 week therapy | 143.4 (34.2) | 168.0 (38.5) | 0.016 |
After 12 week therapy | 137.0 (26.4) | 163.7 (39.5) | 0.006 |
P value* | 0.018 | 0.483 | – |
Change from baseline | −26.7 | −1.9 | 0.011 |
After 4 week without therapy | 140.0 (26.5) | 170.1 (50.3) | 0.013 |
HbA1c (%) | |||
Baseline | 8.4 (2.0) | 8.0 (2.2) | 0.239 |
After 4 week therapy | 8.2 (1.8) | 8.9 (1.4) | 0.740 |
After 8 week therapy | 7.7 (2.1) | 8.6 (2.2) | 0.675 |
After 12 week therapy | 7.7 (2.0) | 9.0 (2.2) | 0.101 |
P value* | 0.137 | 0.978 | – |
Change from baseline | −0.8 | 1.0 | 0.001 |
After 4 week without therapy | 7.0 (1.5) | 8.5 (1.2) | 0.009 |
Cholesterol (mg/dl) | |||
Baseline | 178.1 (31.2) | 177.3 (33.7) | 0.480 |
After 4 week therapy | 160.8 (31.1) | 171.2 (30.1) | 0.137 |
After 8 week therapy | 148.1 (31.9) | 171.4 (37.8) | 0.017 |
After 12 week therapy | 141.2 (31.9) | 166.9 (39.8) | 0.014 |
P value* | < 0.001 | 0.311 | – |
Change from baseline | −37.3 | −10.4 | 0.085 |
After 4 week without therapy | 147.6 (29.7) | 170.0 (34.3) | 0.280 |
Triglyceride (mg/dl) | |||
Baseline | 161.1 (39.1) | 172.2 (81.2) | 0.221 |
After 4 week therapy | 154.0 (45.3) | 168.0 (58.0) | 0.117 |
After 8 week therapy | 154.0 (48.8) | 165.0 (56.6) | 0.230 |
After 12 week therapy | 148.8 (45.7) | 164.3 (56.3) | 0.092 |
P value* | 0.045 | 0.045 | – |
Change from baseline | −10.4 | −11.4 | 0.283 |
After 4 week without therapy | 149.8 (40.1) | 167.6 (58.3) | 0.118 |
LDLC (mg/dl) | |||
Baseline | 115.1 (22.4) | 94.5 (23.1) | 0.008 |
After 4 week therapy | 106.8 (22.5) | 92.7 (26.6) | 0.243 |
After 8 week therapy | 99.7 (21.1) | 96.1 (27.6) | 0.003 |
After 12 week therapy | 94.1 (19.9) | 90.6 (17.9) | 0.046 |
P value* | < 0.001 | 0.482 | – |
Change from baseline | −21.0 | −4.3 | 0.010 |
After 4 week without therapy | 105.0 (24.6) | 100.5 (31.4) | 0.636 |
HDLC (mg/dl) | |||
Baseline | 43.1 (8.8) | 43.5 (7.2) | 0.992 |
After 4 week therapy | 44.2 (9.3) | 41.1 (7.9) | 0.054 |
After 8 week therapy | 45.6 (9.2) | 42.0 (6.1) | 0.726 |
After 12 week therapy | 49.1 (7.9) | 41.9 (10.0) | 0.300 |
P value* | 0.316 | 0.607 | – |
Change from baseline | 4.7 | −4.4 | 0.011 |
After 4 week without therapy | 42.5 (8.1) | 40.7 (6.5) | 0.969 |
Cholesterol/HDLC ratio (mg/dl) | |||
Baseline | 4.3 (1.2) | 4.2 (1.0) | 0.771 |
After 4 week therapy | 3.9 (1.3) | 4.4 (1.3) | 0.052 |
After 8 week therapy | 3.4 (1.2) | 4.2 (1.6) | 0.220 |
After 12 week therapy | 3.0 (0.8) | 4.2 (1.2) | 0.048 |
P value* | 0.021 | 0.332 | – |
Change from baseline | −1.4 | −0.2 | 0.333 |
After 4 week without therapy | 3.6 (0.9) | 4.5 (1.4) | 0.636 |