Table 3.
Diet effects on clinical measures, intention-to-treat analysis
|
Diet period |
Supplement period |
Effect Size
e
|
p value f | |||||
|---|---|---|---|---|---|---|---|---|
|
Baseline |
16 weeks |
Change |
Baseline |
16 weeks |
Change |
|||
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||
| Body weight (kg) (N=42) |
76.7 (20.2) |
73.1 (19.4) |
-3.6 (3.8)a |
74.9 (19.7) |
74.8 (19.9) |
-0.1 (2.4) |
-3.5 (4.4) |
< 0.001 |
| BMI (N=42) |
27.5 (6.2) |
26.2 (5.9) |
-1.3 (1.3)a |
26.9 (6.0) |
26.8 (6.1) |
0.0 (0.9) |
-1.3 (1.6) |
< 0.001 |
| Total cholesterol (N=41)g |
189.5 (38.8) |
175.8 (42.7) |
-13.7 (32.0)c |
184.7 (33.6) |
185.4 (38.0) |
0.7 (26.2) |
-14.4 (40.5) |
0.03 |
| HDL (N=42) |
61.1 (15.7) |
55.3 (14.3) |
-5.8 (15.2)d |
61.9 (14.1) |
60.7 (14.3) |
-1.2 (10.0) |
-4.6 (19.0) |
0.12 |
| LDL (N=41) |
108.8 (33.6) |
99.8 (34.5) |
-9.0 (26.3)d |
103.1 (28.3) |
105.5 (32.7) |
2.3 (22.7) |
-11.1 (33.6) |
0.04 |
| Ratio (N=41) |
3.2 (0.9) |
3.3 (0.9) |
0.1 (0.8) |
3.1 (0.7) |
3.2 (0.8) |
0.1 (0.7) |
-0.1 (1.2) |
0.75 |
| Triglycerides (N=41) |
95.9 (44.3) |
102.7 (42.1) |
6.8 (51.9) |
96.3 (35.1) |
96.2 (51.7) |
-0.1 (49.2) |
6.9 (77.6) |
0.57 |
| Log triglycerides (N=41) |
1.94 (0.20) |
1.98 (0.18) |
0.04 (0.21) |
1.96 (0.16) |
1.94 (0.18) |
-0.01 (0.15) |
0.05 (0.28) |
0.25 |
| VAS (cm) (N=41) |
6.0 (2.7) |
3.8 (3.0) |
-2.1 (3.2)b |
4.9 (2.8) |
4.2 (2.8) |
-0.7 (2.3) |
-1.4 (4.0) |
0.03 |
| Headache number (per wk) (N=40)h |
2.1 (1.4) |
1.8 (1.8) |
-0.3 (1.2) |
2.2 (2.1) |
1.8 (2.2) |
-0.4 (0.9) |
0.1 (1.3) |
0.61 |
| Headache intensity (N=37) |
4.3 (1.9) |
3.3 (1.9) |
-1.0 (1.7)c |
3.8 (2.0) |
3.3 (2.0) |
-0.5 (1.5) |
-0.5 (2.5) |
0.20 |
| Headache duration, hrs (N=38) |
6.2 (4.0) |
5.2 (4.0) |
-0.9 (2.9) |
5.2 (3.9) |
4.8 (4.0) |
-0.3 (2.5) |
-0.6 (4.4) |
0.44 |
| Headache days (per wk) (N=40) |
2.0 (1.4) |
1.8 (1.5) |
-0.3 (1.1) |
2.1 (1.7) |
1.7 (1.6) |
-0.4 (0.8) |
0.1 (1.3) |
0.62 |
| Medicated headache number (N=36) |
1.4 (1.1) |
1.1 (1.5) |
-0.2 (1.5) |
1.4 (1.5) |
1.1 (1.1) |
-0.3 (0.8) |
0.0 (1.7) |
0.90 |
| % headaches medicated (N=36) | 65.1 (33.5) | 46.0 (32.7) | -19.2 (39.3)c | 52.6 (32.4) | 49.4 (34.4) | -3.2 (21.2) | -16.0 (48.5) | 0.04 |
Abbreviations: BMI Body Mass Index, HDL high-density lipoprotein cholesterol, LDL low-density lipoprotein cholesterol, Ratio= Total cholesterol/HDL, VAS visual analog pain scale, worst pain last 2 weeks, SD standard deviation.
ap<0.0001, bp<0.001, cp<0.01, dp<0.05, all from within-group T-tests.
eEffect size is difference between diet treatment effect and supplement treatment effect.
fp value is from between group T-test.
gOne participant with incomplete blood lipids data was excluded from analyses of total, HDL, and LDL cholesterol and triglycerides. Cholesterol and triglycerides are reported in mg/dl.
hVariable Ns reflect the fact that participants with incomplete headache diary data were excluded from analysis of headache number, intensity, duration, days, and/or medication rates as appropriate.