Table 2.
Secondary outcomes (Anthropometric parameters) | Period | Group | P* | (P inter) | |||
---|---|---|---|---|---|---|---|
Placebo group (N = 55) | TJ001 group (N = 57) | ||||||
Mean ± S.D. | (P intra) | Mean ± S.D. | (P intra) | ||||
Weight, kg | Baseline | 83.7 ± 14.4 | — | 82.2 ± 10.5 | — | 0.5458 | — |
week 4 | 83.2 ± 14.8 | 80.9 ± 10.2 | 0.3272 | ||||
week 8 | 82.7 ± 13.8 | 80.7 ± 10.3 | 0.3900 | ||||
week 12 | 82.8 ± 15.1 | 80.3 ± 10.5 | 0.3080 | ||||
Δ0–12 | −0.88 ± 3.05 | 0.0371 | −1.95 ± 3.35 | <0.0001 | — | 0.0708 | |
ANOVA | visit X group interaction: P = 0.0816 | ||||||
Body mass index (BMI), kg/cm2 | Baseline | 31.9 ± 3.80 | — | 31.8 ± 2.60 | — | 0.8598 | — |
week 4 | 31.6 ± 3.90 | 31.2 ± 2.60 | 0.5660 | ||||
week 8 | 31.4 ± 3.90 | 31.2 ± 2.80 | 0.7407 | ||||
week 12 | 31.4 ± 4.10 | 31.0 ± 2.80 | 0.5420 | ||||
Δ0–12 | −0.45 ± 1.17 | 0.0061 | −0.75 ± 1.27 | <0.0001 | — | 0.1680 | |
ANOVA | visit X group interaction: P = 0.3703 | ||||||
Waist circumference (WC), cm | Baseline | 100.4 ± 9.50 | — | 99.6 ± 7.00 | — | 0.6259 | — |
week 4 | 99.7 ± 9.60 | 97.6 ± 7.40 | 0.1932 | ||||
week 8 | 98.6 ± 9.30 | 97.3 ± 7.70 | 0.3938 | ||||
week 12 | 97.3 ± 11.70 | 96.3 ± 7.90 | 0.6056 | ||||
Δ0–12 | −3.09 ± 8.57 | 0.010 | −3.29 ± 4.54 | <0.0001 | — | 0.7665 | |
ANOVA | visit X group interaction: P = 0.4725 | ||||||
Hip circumference (HC), cm | Baseline | 110.4 ± 8.80 | — | 109.9 ± 6.00 | — | 0.7096 | — |
week 4 | 109.8 ± 8.30 | 108.4 ± 5.70 | 0.3027 | ||||
week 8 | 109.2 ± 8.40 | 108.1 ± 5.50 | 0.4026 | ||||
week 12 | 108.6 ± 8.30 | 107.6 ± 5.70 | 0.4330 | ||||
Δ0–12 | −1.82 ± 3.48 | 0.0003 | −2.35 ± 3.51 | <0.0001 | — | 0.3183 | |
ANOVA | visit X group interaction: P = 0.3456 | ||||||
Waist/hip ratio (WHR) | Baseline | 0.91 ± 0.05 | — | 0.90 ± 0.05 | — | 0.6934 | — |
week 4 | 0.91 ± 0.05 | 0.90 ± 0.05 | 0.4217 | ||||
week 8 | 0.90 ± 0.04 | 0.90 ± 0.06 | 0.6775 | ||||
week 12 | 0.90 ± 0.05 | 0.89 ± 0.05 | 0.4159 | ||||
Δ0–12 | −0.0073 ± 0.04 | 0.1307 | −0.0114 ± 0.03 | 0.0108 | — | 0.4058 | |
ANOVA | visit X group interaction: P = 0.7758 |
P*: A P value for between-group comparison at each visit and visit X group interaction using ANOVA.
(P intra): A P value for within-group comparison between baseline and 5th visit by paired t-test.
(P inter): A P value for between-group comparison after 12-week treatment using ANCOVA (baseline as covariate).
Δ0–12: Changes between baseline and the 5th visit (after 12-week treatment).
P < 0.05 were considered statistically significant.