Table 3 Sensitivity analyses on primary and secondary outcomes at week 16 and 32 in intention-to-treat analysesa
Outcome | Control Group (n = 105) | H1 Group (n = 105) | H3 Group (n = 105) | Group effect | H1 group vs. control group | H3 group vs. control group | H3 group vs. H1 group | |||
|---|---|---|---|---|---|---|---|---|---|---|
Adjusted mean difference (95% CI) | P Value | Adjusted mean difference (95% CI) | P Value | Adjusted mean difference (95% CI) | P Value | |||||
Mean fat mass (SD), kg | ||||||||||
Week 0 | 28.5 (5.9); (n = 105) | 29.4 (5.6); (n = 105) | 29.1 (6.6); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 28.8 (6.4); (n = 99) | 28.7 (5.9); (n = 99) | 27.8 (6.6); (n = 99) | <0.0001 | −0.8 (−1.3 to −0.2) | 0.0075 | −1.2 (−1.8 to −0.7) | <0.0001 | −0.5 (−1.1 to 0.1) | 0.0992 |
Week 32 | 27.9 (6.3); (n = 95) | 28.3 (5.9); (n = 93) | 28.1 (7.2); (n = 94) | 0.3265 | −0.3 (−1.0 to 0.5) | 0.4851 | −0.3 (−1.0 to 0.3) | 0.3295 | −0.1 (−0.8 to 0.7) | 0.8192 |
Secondary outcomes | ||||||||||
Mean fat percentage (SD), % | ||||||||||
Week 0 | 38.2 (4.9); (n = 105) | 38.5 (5.0); (n = 105) | 38.3 (4.8); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 38.4 (4.7); (n = 99) | 37.9 (5.3); (n = 99) | 37.4 (5.0); (n = 99) | <0.0001 | −0.8 (−1.3 to −0.3) | 0.0021 | −1.1 (−1.6 to −0.6) | <0.0001 | −0.3 (−0.8 to 0.2) | 0.2391 |
Week 32 | 37.8 (5.1); (n = 95) | 37.8 (5.3); (n = 93) | 37.5 (5.1); (n = 94) | 0.4052 | −0.2 (−0.8 to 0.3) | 0.4177 | −0.2 (−0.8 to 0.3) | 0.4100 | −0.0 (−0.6 to 0.6) | 0.9826 |
Mean lean mass (SD), kg | ||||||||||
Week 0 | 44.5 (9.0); (n = 105) | 45.6 (10.6); (n = 105) | 44.9 (9.5); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 44.2 (8.8); (n = 99) | 45.5 (10.6); (n = 99) | 44.7 (9.8); (n = 99) | 0.1491 | 0.4 (−0.0 to 0.9) | 0.0561 | 0.3 (−0.1 to 0.7) | 0.1547 | −0.1 (−0.6 to 0.3) | 0.5903 |
Week 32 | 44.0 (9.1); (n = 95) | 45.1 (10.5); (n = 93) | 44.7 (9.9); (n = 94) | 0.7820 | 0.1 (−0.4 to 0.6) | 0.7254 | −0.1 (−0.5 to 0.4) | 0.7750 | −0.2 (−0.6 to 0.3) | 0.5359 |
Mean body weight (SD), kg | ||||||||||
Week 0 | 75.0 (12.9); (n = 105) | 77.0 (14.3); (n = 105) | 76.1 (14.3); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 74.9 (13.5); (n = 99) | 76.2 (14.6); (n = 99) | 74.5 (14.6); (n = 99) | 0.0094 | −0.4 (−1.1 to 0.3) | 0.2497 | −0.9 (−1.5 to −0.2) | 0.0094 | −0.4 (−1.2 to 0.3) | 0.2251 |
Week 32 | 73.8 (13.4); (n = 95) | 75.4 (14.5); (n = 93) | 74.8 (15.3); (n = 94) | 0.4236 | −0.3 (−1.2 to 0.7) | 0.5956 | −0.4 (−1.2 to 0.5) | 0.4258 | −0.1 (−1.1 to 0.9) | 0.8426 |
Mean BMI (SD), kg/m2 | ||||||||||
Week 0 | 28.3 (3.6); (n = 105) | 28.7 (3.7); (n = 105) | 29.1 (4.2); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 28.2 (3.9); (n = 99) | 28.4 (3.8); (n = 99) | 28.5 (4.1); (n = 99) | 0.0039 | −0.1 (−0.4 to 0.1) | 0.3107 | −0.4 (−0.6 to −0.1) | 0.0039 | −0.2 (−0.5 to 0.0) | 0.0932 |
Week 32 | 27.9 (3.8); (n = 95) | 28.1 (3.7); (n = 93) | 28.6 (4.3); (n = 94) | 0.3113 | −0.1 (−0.4 to 0.3) | 0.7464 | −0.2 (−0.5 to 0.2) | 0.3101 | −0.1 (−0.5 to 0.3) | 0.5343 |
Mean waist circumference (SD), cm | ||||||||||
Week 0 | 94.2 (8.6); (n = 105) | 95.4 (9.0); (n = 105) | 95.0 (10.3); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 93.5 (9.3); (n = 99) | 92.6 (9.8); (n = 99) | 92.4 (11.5); (n = 99) | 0.0009 | −1.9 (−3.0 to −0.9) | 0.0004 | −1.9 (−3.1 to −0.8) | 0.0010 | 0.0 (−1.1 to 1.2) | 0.9929 |
Week 32 | 93.0 (9.6); (n = 95) | 92.3 (10.3); (n = 93) | 92.7 (12.3); (n = 94) | 0.0111 | −1.5 (−2.9 to −0.1) | 0.0315 | −1.7 (−3.1 to −0.4) | 0.0118 | −0.2 (−1.7 to 1.2) | 0.7727 |
Mean systolic blood pressure (SD), mm Hg | ||||||||||
Week 0 | 119.6 (15.6); (n = 105) | 118.9 (13.8); (n = 105) | 122.8 (15.9); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 117.7 (13.7); (n = 99) | 118.2 (11.7); (n = 99) | 119.3 (16.3); (n = 99) | 0.8795 | 0.9 (−1.5 to 3.2) | 0.4732 | −0.2 (−2.9 to 2.4) | 0.8678 | −1.1 (−3.6 to 1.4) | 0.3962 |
Week 32 | 117.2 (14.0); (n = 95) | 117.5 (13.0); (n = 93) | 119.0 (14.4); (n = 94) | 0.4737 | 0.2 (−2.4 to 2.8) | 0.8644 | −0.9 (−3.5 to 1.6) | 0.4673 | −1.2 (−3.9 to 1.6) | 0.4132 |
Mean diastolic blood pressure (SD), mm Hg | ||||||||||
Week 0 | 76.1 (10.4); (n = 105) | 75.0 (9.8); (n = 105) | 77.2 (11.6); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 75.2 (9.5); (n = 99) | 74.2 (9.7); (n = 99) | 74.1 (11.5); (n = 99) | 0.0962 | −0.4 (−2.3 to 1.4) | 0.6435 | −1.6 (−3.5 to 0.3) | 0.0945 | −1.2 (−3.1 to 0.7) | 0.2103 |
Week 32 | 74.0 (10.1); (n = 95) | 73.1 (9.0); (n = 93) | 74.8 (10.8); (n = 94) | 0.5818 | −0.6 (−2.4 to 1.3) | 0.5559 | −0.5 (−2.5 to 1.4) | 0.5859 | 0.0 (−2.0 to 2.0) | 0.9934 |
Mean fasting plasma glucose level (SD), mmol/Lb | ||||||||||
Week 0 | 5.1 (0.7); (n = 105) | 5.1 (1.3); (n = 105) | 5.1 (0.7); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 5.1 (0.8); (n = 99) | 5.0 (0.9); (n = 98) | 5.1 (0.6); (n = 99) | 0.1682 | −0.15 (−0.28 to −0.01) | 0.0304 | −0.10 (−0.24 to 0.04) | 0.1734 | 0.05 (−0.08 to 0.17) | 0.4442 |
Week 32 | 5.1 (1.0); (n = 95) | 4.9 (0.6); (n = 92) | 5.0 (0.5); (n = 94) | 0.2288 | −0.15 (−0.35 to 0.04) | 0.1235 | −0.12 (−0.32 to 0.08) | 0.2323 | 0.03 (−0.12 to 0.19) | 0.6683 |
Mean total cholesterol level (SD), mmol/Lb | ||||||||||
Week 0 | 5.6 (1.0); (n = 105) | 5.4 (0.9); (n = 105) | 5.5 (1.1); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 5.5 (1.1); (n = 99) | 5.2 (0.9); (n = 98) | 5.4 (1.0); (n = 99) | 0.9969 | −0.11 (−0.28 to 0.06) | 0.2047 | 0.00 (−0.18 to 0.18) | 0.9847 | 0.11 (−0.06 to 0.29) | 0.2073 |
Week 32 | 5.4 (1.2); (n = 95) | 5.2 (1.0); (n = 92) | 5.2 (0.9); (n = 94) | 0.4930 | −0.10 (−0.32 to 0.11) | 0.3449 | −0.07 (−0.27 to 0.13) | 0.4970 | 0.03 (−0.17 to 0.23) | 0.7484 |
Mean HDL-C level (SD), mmol/Lb | ||||||||||
Week 0 | 1.5 (0.3); (n = 105) | 1.5 (0.3); (n = 105) | 1.4 (0.3); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 1.4 (0.3); (n = 99) | 1.4 (0.3); (n = 98) | 1.4 (0.3); (n = 99) | 0.6316 | 0.00 (−0.04 to 0.05) | 0.9057 | 0.01 (−0.04 to 0.06) | 0.6296 | 0.01 (−0.04 to 0.06) | 0.6950 |
Week 32 | 1.4 (0.3); (n = 95) | 1.4 (0.3); (n = 92) | 1.4 (0.3); (n = 94) | 0.5325 | 0.02 (−0.03 to 0.07) | 0.3793 | 0.02 (−0.04 to 0.07) | 0.5391 | −0.01 (−0.06 to 0.05) | 0.8204 |
Mean LDL-C level (SD), mmol/Lb | ||||||||||
Week 0 | 3.5 (0.9); (n = 105) | 3.4 (0.7); (n = 105) | 3.4 (0.9); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 3.5 (0.8); (n = 99) | 3.2 (0.7); (n = 98) | 3.4 (0.9); (n = 99) | 0.9870 | −0.12 (−0.26 to 0.02) | 0.1043 | 0.00 (−0.14 to 0.15) | 0.9692 | 0.12 (−0.03 to 0.27) | 0.1093 |
Week 32 | 3.4 (1.0); (n = 95) | 3.2 (0.8); (n = 92) | 3.2 (0.8); (n = 94) | 0.3082 | −0.10 (−0.28 to 0.09) | 0.3039 | −0.09 (−0.26 to 0.08) | 0.3105 | 0.01 (−0.16 to 0.18) | 0.9171 |
Mean triglyceride level (SD), mmol/Lb | ||||||||||
Week 0 | 1.4 (0.7); (n = 105) | 1.2 (0.5); (n = 105) | 1.4 (0.8); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 1.3 (0.7); (n = 99) | 1.2 (0.5); (n = 98) | 1.3 (0.9); (n = 99) | 0.8018 | −0.00 (−0.15 to 0.14) | 0.9586 | −0.02 (−0.22 to 0.17) | 0.8009 | −0.02 (−0.19 to 0.14) | 0.8010 |
Week 32 | 1.3 (0.8); (n = 95) | 1.1 (0.5); (n = 92) | 1.4 (0.9); (n = 94) | 0.9220 | −0.06 (−0.22 to 0.10) | 0.4716 | 0.01 (−0.17 to 0.18) | 0.9125 | 0.07 (−0.08 to 0.22) | 0.3770 |
Mean VO2max (SD), mL/kg/min | ||||||||||
Week 0 | 26.8 (4.4); (n = 105) | 26.4 (5.2); (n = 105) | 25.9 (5.1); (n = 105) | – | – | – | – | – | – | – |
Week 16 | 26.6 (4.9); (n = 97) | 28.0 (6.1); (n = 97) | 28.7 (5.3); (n = 97) | <0.0001 | 1.5 (0.5 to 2.5) | 0.0026 | 2.9 (1.9 to 3.9) | <0.0001 | 1.4 (0.3 to 2.4) | 0.0109 |
Week 32 | 26.4 (5.0); (n = 91) | 26.9 (6.3); (n = 91) | 27.3 (5.8); (n = 89) | 0.0056 | 0.8 (−0.3 to 1.9) | 0.1344 | 1.6 (0.5 to 2.8) | 0.0057 | 0.8 (−0.4 to 2.0) | 0.1777 |