Table 1. Outcomes measured before, during and/or after the mIER and mCER interventions of the ICECAP trial
Measurement&
No
. mIER No
. mCER
Difference between groups
P value
b
Self-reported energy intake, kJ per day
0 weeks 30 10470 (9720 to 11200) 31 10420 (9490 to 11400) 50 (-1170 to 1270) 0.930
During the 12 weeks of energy restriction (excluding energy balance)
27 7003 (6360 to 7640) 23 6750 (6030 to 7470) 253 (-760 to 1270) 0.617
During the 3 weeks of energy balance during or after the energy restriction phase
26 9260 (8430 to 10080) 23 8850 (7950 to 9750) 410 (-830 to 1650) 0.530
Difference from 0-week self-reported energy intake, kJ per day During the 12 weeks of energy
restriction (excluding energy balance)
27 -3470 (-2830 to -4110) 23 -3670 (-2950 to -4390) 200 (-1180 to 780) 0.693
During the 3 weeks of energy balance during or after the energy restriction phase
26 -1610 (-850 to -2360) 23 -1600 (-680 to -2520) 10 (-1200 to 1220) 0.994 2
3
Measurement . mIER . mCER groups Weight, kg
0 weeks 30 76.3 (70.4 to 82.2) 31 78.1 (72.5 to 83.7) -1.8 (-10.1 to 6.5) 0.661
12 weeks* - - 23 74.6 (69.3 to 80.0)a(P < 0.001) -2.5 (-11.5 to 6.5) 0.283
15 weeks 26 72.1 (66.4 to 77.9)a(P < 0.001) 23 75.2 (69.9 to 80.6)a(P < 0.001) -3.1 (-12.1 to 5.9) 0.042 Fat mass, fat-free mass, resting exergy expenditure, and hormonal regulators thereof
Fat mass, kg#
0 weeks 30 18.6 (16.2 to 20.9) 31 20.7 (17.5 to 24.0) -2.1 (-6.3 to 2.0) 0.297
12 weeks* - - 23 18.0 (14.8 to 21.2) a(P < 0.001) -2.7 (-7.3 to 1.9) 0.321
15 weeks 26 15.3 (12.9 to 17.7) a(P < 0.001) 23 18.2 (15.0 to 21.3) a(P < 0.001) -2.9 (-7.4 to 1.7) 0.207 Fat mass, %
0 weeks 30 25.4 (23.2 to 27.5) 31 27.4 (24.3 to 30.6) -2.0 (-6.0 to 1.9) 0.297
12 weeks* - - 23 24.8 (21.4 to 28.1) a(P < 0.001) -3.0 (-7.8 to 1.8) 0.230
15 weeks 26 21.8 (19.2 to 24.3) a(P < 0.001) 23 24.8 (21.5 to 28.1) a(P < 0.001) -3.0 (-7.8 to 1.8) 0.221 Leptin, pg/mL
0 weeks 17 2610 (1320 to 3900) 16 3570 (1700 to 5440) -960 (-3320 to 1400) 0.413
12 weeks* - - 11 2650 (677 to 4630)a(P = 0.001) -730 (-3090 to 1630) 0.820
15 weeks 13 1920 (736 to 3100)a(P = 0.038) 11 2890 (949 to 4840)a(P = 0.012) -970 (-3310 to 1360) 0.817
Measurement . mIER . mCER groups Fat-free mass, kg#
0 weeks 30 57.4 (52.9 to 61.9) 31 57.1 (52.5 to 61.7) 0.3 (-6.3 to 6.8) 0.933
12 weeks* - - 23 56.7 (52.1 to 61.2) 0.0 (-7.3 to 7.4) 0.309
15 weeks 26 56.7 (52.2 to 61.2) a(P < 0.001) 23 57.0 (52.5 to 61.6) -0.3 (-7.7 to 7.0) 0.061 Insulin like growth factor-1, ng/mL
0 weeks 17 213 (195 to 231) 16 217 (190 to 245) -4 (-38 to 29) 0.782
12 weeks* - - 11 196 (173 to 218)a(P = 0.002) -7 (-37 to 23) 0.682
15 weeks 13 189 (171 to 206)a(P = 0.013) 11 206 (179 to 232) -17 (-50 to 16) 0.191
Testosterone, ng/mL
0 weeks 17 2.11 (1.18 to 3.04) 16 1.53 (0.66 to 2.40) 0.58 (-0.76 to 1.90) 0.388
12 weeks* - - 11 1.46 (0.65 to 2.27) 0.41 (-0.79 to 1.61) 0.769
15 weeks 13 1.87 (1.05 to 2.69) 11 1.16 (0.45 to 1.87)a(P = 0.048) 0.71 (-0.42 to 1.84) 0.308 Resting energy expenditure, kJ per day
0 weeks 30 7870 (7260 to 8480) 31 8160 (7500 to 8810) -290 (-1130 to 560) 0.625
12 weeks* - - 23 7250 (6530 to 7980) a(P < 0.001) -250 (-1250 to 750) 0.635
15 weeks 26 7000 (6420 to 7580) a(P < 0.001) 23 7200 (6550 to 7850) a(P < 0.001) -200 (-1160 to 760) 0.743 Free 3,3′,5-triiodothyronine, pmol/L
0 weeks 17 4.36 (4.02 to 4.70) 16 4.24 (3.86 to 4.62) 0.12 (-0.41 to 0.65) 0.655
Measurement . mIER . mCER groups
12 weeks* - - 11 3.91 (3.60 to 4.22)a(P = 0.020) -0.07 (-0.58 to 0.44) 0.501
15 weeks 13 3.84 (3.47 to 4.21)a(P = 0.013) 11 4.05 (3.70 to 4.40) -0.21 (-0.74 to 0.32) 0.164 Physical activity and sleep
Physical activity energy expenditure, kJ per day
0 weeks 7 2120 (1710 to 2540) 5 2040 (1720 to 2360) 80 (-560 to 730) 0.772
7 or 6 weeks 7 1380 (1000 to 1760) a(P = 0.026) 5 1930 (1260 to 2590) -550 (-1360 to 260) 0.165
15 or 12 weeks 7 1790 (1280 to 2310) 5 1950 (1320 to 2580) -160 (-1070 to 760) 0.727
Time in sedentary activity, %
0 weeks 7 72.7 (68.6 to 76.8) 5 70.3 (66.6 to 73.9) 2.4 (-4.2 to 9.0) 0.432
7 or 6 weeks 7 77.0 (74.8 to 79.2) 5 69.4 (63.4 to 75.3) 7.6 (1.2 to 14.0) 0.042
15 or 12 weeks 7 75.5 (71.9 to 79.0) 5 69.6 (63.4 to 75.7) 5.9 (-1.6 to 13.4) 0.153
Time in vigorous activity, %
0 weeks 7 0.25 (0.00 to 0.51) 5 0.67 (0.20 to 1.14) -0.42 (-0.98 to 0.14) 0.133
7 or 6 weeks 7 0.10 (0.01 to 0.22) 5 0.18 (0.00 to 0.36) -0.08 (-0.34 to 0.18) 0.620
15 or 12 weeks 7 0.47 (0.10 to 0.84) 5 0.63 (0.01 to 1.37) -0.16 (-1.01 to 0.69) 0.691
Steps per day
0 weeks 7 9010 (6090 to 11930) 5 9450 (7930 to 10970) -440 (-4680 to 3800) 0.821
Measurement . mIER . mCER groups
7 or 6 weeks 7 6320 (5280 to 7360) 5 7850 (6200 to 9510) -1530 (-3630 to 570) 0.148
15 or 12 weeks 7 6910 (5750 to 8080) 5 9110 (7180 to 11030) -2200 (-4550 to 160) 0.078
Epworth sleepiness scale, score out of 24 (higher score = higher sleepiness)
0 weeks 30 7.46 (6.01 to 8.91) 31 5.26 (4.18 to 6.34) 2.20 (0.37 to 4.03) 0.019
7 or 6 weeks 28 7.64 (6.11 to 9.17) 28 5.52 (4.36 to 6.68) 2.12 (0.19 to 4.05) 0.507
15 or 12 weeks 22 11.79 (10.16 to 13.42) a(P <
0.001)
16 8.64 (6.80 to 10.48) a(P < 0.001) 3.15 (0.62 to 5.68) 0.081
Pittsburgh sleep quality index, score out of 21 (higher score = lower sleep quality)
0 weeks 30 5.36 (4.28 to 6.44) 31 5.34 (4.46 to 6.22) 0.02 (-1.39 to 1.43) 0.985
7 or 6 weeks 28 5.11 (4.01 to 6.21) 28 5.50 (4.54 to 6.46) -0.39 (-1.89 to 1.11) 0.530
15 or 12 weeks 22 6.36 (5.28 to 7.44) 16 6.00 (4.92 to 7.08) 0.36 (-1.21 to 1.93) 0.638
Muscle performance Strength
Peak torque during maximum-effort 3-repetition set, N m Hamstrings
0 weeks 30 91.5 (78.3 to 105.0) 31 92.2 (80.7 to 104.0) -0.7 (-18.6 to 17.2) 0.942
12 weeks* - - 23 99.2 (84.6 to 114.0) a(P = 0.021) -2.5 (-23.0 to 18.0) 0.700
Measurement . mIER . mCER groups
15 weeks 26 96.7 (83.3 to 110.0) 23 100.0 (85.4 to 114.0) a(P =
0.011)
-3.3 (-23.7 to 17.1) 0.574
Quadriceps
0 weeks 30 230 (153 to 307) 31 177 (153 to 201) 53 (-25 to 131) 0.178
12 weeks* - - 23 179 (154 to 205) 56 (-23 to 133) 0.688
15 weeks 26 235 (311 to 158) 23 180 (155 to 204) 55 (-23 to 132) 0.702
Biceps
0 weeks 30 55.2 (47.3 to 63.2) 31 54.0 (44.8 to 63.2) 1.2 (-11.3 to 13.9) 0.841
12 weeks* - - 23 53.8 (45.6 to 62.0) 0.9 (-11.1 to 12.9) 0.884
15 weeks 26 54.7 (46.4 to 62.9) 23 56.2 (48.0 to 64.3) -1.5 (-13.5 to 10.5) 0.191
Triceps
0 weeks 30 49.9 (42.6 to 57.3) 31 51.9 (40.1 to 63.6) -2.0 (-16.7 to 12.7) 0.793
12 weeks* - - 23 52.6 (41.0 to 64.2) -4.5 (-18.8 to 9.8) 0.210
15 weeks 26 48.1 (41.5 to (54.8) 23 52.9 (41.4 to 64.4) -4.8 (-19.0 to 9.4) 0.152
Power during maximum-effort 3-repetition set, W Hamstrings
0 weeks 30 61.4 (53.3 to 69.5) 31 63.6 (54.4 to 72.8) -2.2 (-14.9 to 10.5) 0.733
12 weeks* - - 23 69.0 (58.7 to 79.2) a(P = 0.007) -2.2 (-16.0 to 11.6) 0.962
Measurement . mIER . mCER groups
15 weeks 26 66.8 (58.4 to 75.2) a (P = 0.020) 23 70.4 (59.9 to (80.8) a(P < 0.001) -3.6 (-17.6 to 10.4) 0.642 Quadriceps
0 weeks 30 118 (102 to 134) 31 112 (94 to 129) 6 (-18 to 30) 0.604
12 weeks* - - 23 120 (102 to 138) a(P = 0.009) 3 (-23 to 29) 0.518
15 weeks 26 123 (106 to 140) 23 121 (103 to 138) a(P = 0.008) 2 (-22 to 28) 0.432
Biceps
0 weeks 30 41.4 (34.4 to 48.3) 31 43.1 (35.0 to 51.2) -1.7 (-12.8 to 9.4) 0.755
12 weeks* - - 23 41.8 (34.2 to 49.4) -2.2 (-12.7 to 8.3) 0.712
15 weeks 26 39.6 (33.0 to 46.3) 23 42.8 (35.6 to 50.1) -3.2 (-13.4 to 7.0) 0.365
Triceps
0 weeks 30 34.8 (28.6 to 41.1) 31 36.6 (26.8 to 46.3) -1.8 (-14.1 to 10.5) 0.781
12 weeks* - - 23 39.2 (29.3 to 49.0) -4.3 (-16.5 to 7.9) 0.165
15 weeks 26 34.9 (29.1 to 40.8) 23 38.1 (29.1 to 47.2) -3.2 (-14.6 to 8.2) 0.517
Total work during maximum-effort 3-repetition set, J Hamstrings
0 weeks 30 298 (260 to 336) 31 330 (269 to 391) -32 (-108 to 45) 0.415
12 weeks* - - 23 317 (259 to 375) -6 (-80 to 63) 0.131
15 weeks 26 311 (271 to 351) 23 321 (264 to 378) -10 (-83 to 63) 0.200
Measurement . mIER . mCER groups
Quadriceps
0 weeks 30 537 (465 to 610) 31 539 (424 to 655) -2 (-147 to 142) 0.980
12 weeks*^ - - 23 517 (408 to 626) 13 (-124 to 151) 0.375
15 weeks 26 530 (459 to 602) 23 515 (407 to 622) 15 (-121 to 152) 0.411
Biceps
0 weeks 30 221 (186 to 256) 31 254 (174 to 333) -33 (-125 to 61) 0.481
12 weeks* - - 23 239 (160 to 317) -25 (-115 to 67) 0.425
15 weeks 26 214 (181 to 247) 23 211 (179 to 244) 3 (-45 to 51) 0.333
Triceps
0 weeks 30 176 (146 to 206) 31 204 (122 to 286) -28 (-122 to 66) 0.561
12 weeks* - - 23 209 (129 to 290) -29 (-121 to 63) 0.722
15 weeks 26 180 (152 to 207) 23 176 (137 to 215) 4 (-46 to 54) 0.555
Endurance
Total work during maximum-effort 25-repetition set, J Hamstrings
0 weeks 30 1310 (1110 to 1500) 31 1290 (1120 to 1470) 20 (-260 to 280) 0.928
12 weeks* - - 23 1200 (1030 to 1370) a(P = 0.032) 80 (-160 to 320) 0.176
Measurement . mIER . mCER groups
15 weeks 26 1280 (1130 to 1440) 23 1240 (1050 to 1430) 40 (-210 to 300) 0.590
Quadriceps
0 weeks 30 2570 (2150 to 2990) 31 2490 (2130 to 2850) 80 (-480 to 650) 0.766
12 weeks* - - 23 2330 (1970 to 2680) a(P < 0.001) 200 (-310 to 720) 0.125
15 weeks 26 2530 (2170 to 2890) 23 2350 (2000 to 2690) a(P = 0.001) 180 (-330 to 700) 0.183 Biceps
0 weeks 30 1010 (860 to 1150) 31 898 (757 to 1040) 112 (-98 to 318) 0.295
12 weeks* - - 23 856 (723 to 988) 164 (-65 to 389) 0.343
15 weeks^ 26 1020 (835 to 1200) 23 880 (736 to 1020) 140 (-97 to 373) 0.533
Triceps
0 weeks 30 885 (712 to 1060) 31 780 (646 to 914) 105 (-116 to 326) 0.344
12 weeks* - - 23 792 (655 to 928) 91 (-116 to 299) 0.895
15 weeks 26 883 (733 to 1030) 23 808 (670 to 946) 75 (-133 to 283) 0.855
Work during last third of maximum-effort 25-repetition set, J Hamstrings
0 weeks 30 362 (305 to 418) 31 345 (293 to 397) 17 (-62 to 96) 0.674
12 weeks* - - 23 302 (260 to 344) a(P = 0.006) 37 (-24 to 98) 0.150
Measurement . mIER . mCER groups
15 weeks 26 339 (297 to 380) 23 302 (260 to 345) a(P = 0.007) 37 (-24 to 98) 0.206
Quadriceps
0 weeks 30 726 (610 to 843) 31 680 (571 to 790) 46 (-118 to 210) 0.573
12 weeks* - - 23 611 (515 to 707) a(P = 0.006) 72 (-68 to 212) 0.296
15 weeks 26 683 (587 to 780) 23 619 (525 to 713) a(P = 0.013) 64 (-74 to 202) 0.373
Biceps
0 weeks 30 283 (242 to 324) 31 257 (219 to 295) 26 (-31 to 83) 0.372
12 weeks* - - 23 241 (206 to 276) 33 (-20 to 86) 0.206
15 weeks 26 274 (235 to 313) 23 243 (206 to 280) 31 (-24 to 86) 0.489
Triceps
0 weeks 30 264 (212 to 317) 31 232 (196 to 269) 32 (-32 to 96) 0.321
12 weeks* - - 23 230 (193 to 268) 40 (-27 to 107) 0.494
15 weeks^ 26 270 (215 to 325) 23 229 (193 to 266) 41 (-25 to 107) 0.397
Psychological outcomes
Total mood disturbance (POMS A), score out of 200
0 weeks 30 96 (90 to 102) 31 96 (91 to 100) 0 (-7 to 8) 0.954
7 or 6 weeks^ 28 101 (94 to 108) 28 100 (96 to 105) 1 (-8 to 9) 0.830
Measurement . mIER . mCER groups
15 or 12 weeks 22 107 (102 to 112) a(P = 0.005) 16 106 (99 to 112) a(P < 0.001) 1 (-7 to 10) 0.759 Muscle Dysmorphic Disorder Inventory
Global score on Muscle Dysmorphic Disorder Inventory, score out of 54
0 weeks 30 28.3 (25.6 to 30.9) 31 29.5 (26.7 to 32.2) -1.2 (-5.1 to 2.7) 0.534
7 or 6 weeks 28 30.8 (28.1 to 33.5) a(P < 0.023) 28 29.6 (26.6 to 32.5) 1.2 (-2.9 to 5.3) 0.047
15 or 12 weeks 22 29.2 (26.5 to 31.9) 16 31.7 (28.7 to 34.6) -2.5 (-6.6 to 1.6) 0.299
Drive for size, score out of 25
0 weeks 30 10.5 (8.4 to 12.6) 31 10.1 (8.4 to 11.9) 0.4 (-2.4 to 3.2) 0.810
7 or 6 weeks 28 12.0 (10.1 to 14.0) a(P = 0.006) 28 10.6 (8.7 to 12.5) 1.4 (-1.3 to 4.1) 0.062 15 or 12 weeks 22 12.0 (10.1 to 13.9) a(P = 0.007) 16 11.6 (9.7 to 13.6) a(P = 0.004) 0.4 (-2.4 to 3.2) 0.923
Appearance intolerance, score out of 20
0 weeks 30 9.70 (8.41 to 10.99) 31 10.84 (9.33 to 12.35) -1.14 (-3.14 to 0.94) 0.267
7 or 6 weeks 28 9.43 (8.10 to 10.76) 28 10.10 (8.53 to 11.67) a(P =
0.032)
-0.67 (-2.81 to 1.41) 0.550
15 or 12 weeks 22 7.90 (6.70 to 9.10) a(P < 0.001) 16 9.89 (8.50 to 11.28) a(P = 0.007) -1.99 (-3.88 to -0.12) 0.058 Functional impairment, score out of 20
0 weeks 30 8.10 (6.79 to 9.41) 31 8.52 (7.50 to 9.54) -0.42 (-2.10 to 1.30) 0.625
Measurement . mIER . mCER groups
7 or 6 weeks 28 9.30 (7.97 to 10.63) a(P = 0.023) 28 8.90 (7.74 to 10.06) 0.40 (-1.39 to 2.19) 0.201 15 or 12 weeks 22 9.27 (7.82 to 10.72) a(P = 0.027) 16 10.13 (8.80 to 11.46) a(P =
0.001)
-0.86 (-2.80 to 1.20) 0.489
Three-Factor Eating Questionnaire Cognitive restraint, score out of 20
0 weeks 30 11.9 (10.6 to 13.1) 31 12.9 (11.9 to 13.9) -1.0 (-2.62 to 0.62) 0.217
7 or 6 weeks 28 13.9 (13.0 to 14.9) a(P < 0.001) 28 13.9 (12.8 to 14.9) a(P = 0.017) 0 (-1.44 to 1.44) 0.279 15 or 12 weeks 22 14.7 (13.6 to 15.8) a(P < 0.001) 16 14.5 (13.4 to 15.6) a(P = 0.001) 0.20 (-1.41 to 1.81) 0.220
Disinhibition, score out of 16
0 weeks 30 7.25 (5.77 to 8.73) 31 6.19 (4.99 to 7.38) 1.06 (-0.80 to 3.00) 0.276
7 or 6 weeks 28 7.18 (6.02 to 8.34) 28 6.00 (4.67 to 7.33) 1.18 (-0.57 to 2.97) 0.493
15 or 12 weeks 22 7.57 (6.34 to 8.79) 16 6.59 (5.30 to 7.88) 0.98 (-0.80 to 2.80) 0.615
Behavioural consequences of hunger, score out of 15
0 weeks 30 6.79 (5.63 to 7.94) 31 5.53 (4.45 to 6.61) 1.26 (-0.29 to 2.89) 0.124
7 or 6 weeks 28 7.39 (6.24 to 8.54) 28 6.28 (5.20 to 7.36) 1.11 (-0.49 to 2.69) 0.866
15 or 12 weeks 22 8.00 (6.81 to 9.18) a(P = 0.004) 16 6.81 (5.62 to 8.00) a(P = 0.005) 1.19 (-0.49 to 2.89) 0.659 Eating Disorders Examination Questionnaire
Global score on Eating Disorders Examination Questionnaire, score out of 6
Measurement . mIER . mCER groups
0 weeks 30 1.73 (1.26 to 2.20) 31 1.74 (1.39 to 2.10) -0.01 (-0.59 to 0.57) 0.987
7 or 6 weeks 28 1.66 (1.37 to 1.95) 28 1.63 (1.28 to 1.98) 0.03 (-0.45 to 0.51) 0.815
15 or 12 weeks 22 2.16 (1.77 to 2.55) a(P = 0.010) 16 1.85 (1.50 to 2.20) 0.31 (-0.23 to 0.85) 0.145 Weight concern, score out of 6
0 weeks 30 1.64 (1.17 to 2.11) 31 1.88 (1.45 to 2.31) -0.24 (-0.89 to 0.41) 0.470
7 or 6 weeks 28 1.79 (1.46 to 2.12) 28 2.02 (1.55 to 2.49) -0.23 (-0.82 to 0.36) 0.728
15 or 12 weeks 22 2.29 (1.90 to 2.68) a(P = 0.001) 16 2.09 (1.62 to 2.56) 0.20 (-0.43 to 0.81) 0.264 Shape concern, score out of 6
0 weeks 30 2.13 (1.58 to 2.68) 31 2.14 (1.65 to 2.63) -0.01 (-0.76 to 0.74) 0.967
7 or 6 weeks 28 1.96 (1.53 to 2.39) 28 1.91 (1.42 to 2.40) 0.05 (-0.61 to 0.71) 0.771
15 or 12 weeks 22 2.21 (1.68 to 2.74) 16 1.91 (1.44 to 2.38) 0.30 (-0.43 to 1.01) 0.302
Eating concern, score out of 6
0 weeks 30 0.68 (0.35 to 1.01) 31 0.70 (0.39 to 1.01) -0.02 (-0.48 to 0.44) 0.927
7 or 6 weeks 28 0.81 (0.52 to 1.10) 28 0.83 (0.48 to 1.18) -0.02 (-0.48 to 0.44) 0.992
15 or 12 weeks 22 1.37 (1.02 to 1.72) a(P < 0.001) 16 1.03 (0.64 to 1.42) a(P = 0.020) 0.34 (-0.19 to 0.87) 0.105 Objective binge eating, episodes in the past 28 days
0 weeks 30 1.25 (0.11 to 2.39) 31 1.08 (0.49 to 1.67) 0.17 (-1.06 to 1.4) 0.782
7 or 6 weeks 28 1.38 (0.26 to 2.50) 28 1.06 (0.39 to 1.73) 0.32 (-0.93 to 1.59) 0.416
Measurement . mIER . mCER groups
15 or 12 weeks 22 1.46 (0.24 to 2.67) 16 1.11 (0.40 to 1.82) 0.35 (-1.00 to 1.70) 0.611
Restraint, score out of 6
0 weeks 30 2.37 (2.00 to 2.74) 31 2.31 (1.90 to 2.72) 0.06 (-0.50 to 0.62) 0.819
7 or 6 weeks 28 3.17 (2.78 to 3.56) a(P < 0.001) 28 3.24 (2.87 to 3.61) a(P < 0.001) -0.07 (-0.62 to 0.48) 0.698 15 or 12 weeks 22 3.52 (3.05 to 3.99) a(P < 0.001) 16 3.24 (2.89 to 3.59) a(P < 0.001) 0.28 (-0.30 to 0.86) 0.352
Loss of control over eating, score out of 120
0 weeks 30 42.3 (37.0 to 47.6) 31 41.2 (36.6 to 45.7) 1.1 (-5.9 to 8.1) 0.750
7 or 6 weeks 28 38.5 (34.2 to 42.9) 28 37.1 (32.8 to 41.4) a(P < 0.032) 1.4 (-4.8 to 7.6) 0.762
15 or 12 weeks 22 43.4 (38.1 to 48.7) 16 39.8 (34.6 to 45.0) 3.6 (-3.9 to 11.1) 0.370
Subjective appetite and hormonal regulators thereof Hunger, score out of 100
0 weeks 30 24.0 (13.7 to 34.2) 31 19.1 (9.7 to 28.5) 4.9 (-6.4 to 16.2) 0.517
7 or 6 weeks 28 28.8 (19.6 to 38.0) 28 36.7 (25.9 to 47.5) a(P = 0.012) -7.9 (-19.2 to 3.4) 0.233 15 or 12 weeks 22 34.8 (22.7 to 46.8) 16 62.4 (51.7 to 73.1) a(P < 0.001) -27.6 (-40.7 to -14.5) 0.002
Desire to eat, score out of 100
0 weeks 30 33.3 (21.4 to 45.1) 31 33.1 (20.7 to 45.5) 0.2 (-13.5 to 13.9) 0.981
7 or 6 weeks 28 38.5 (27.7 to 49.2) 28 45.6 (32.2 to 59.0) -7.1 (-20.7 to 6.5) 0.387
Measurement . mIER . mCER groups
15 or 12 weeks 22 41.8 (28.8 to 54.8) 16 64.5 (52.9 to 76.1) a(P < 0.001) -22.7 (-36.9 to -8.5) 0.014 Prospective consumption, score out of 100
0 weeks 30 42.6 (30.6 to 54.6) 31 43.4 (27.6 to 59.1) -0.8 (-16.4 to 14.8) 0.941
7 or 6 weeks 28 53.6 (42.3 to 64.8) 28 52.3 (40.6 to 63.9) 1.3 (-11.8 to 14.2) 0.858
15 or 12 weeks^ 22 54.3 (40.5 to 68.1) 16 63.9 (53.6 to 74.3) a(P = 0.004) -9.6 (-23.8 to 4.6) 0.433 Active ghrelin, pg/mL
0 weeks 17 148 (114 to 182) 16 161 (105 to 217) -13 (-80 to 54) 0.689
12 weeks* - - 11 187 (131 to 244) -37 (-115 to 41) 0.375
15 weeks 13 150 (100 to 200) 11 146 (120 to 172) 4 (-56 to 64) 0.815
Satisfaction, score out of 100
0 weeks 30 67.1 (56.4 to 77.9) 31 72.5 (61.6 to 83.4) -5.4 (-17.7 to 6.9) 0.507
7 or 6 weeks 28 58.2 (46.9 to 69.6) 28 50.0 (34.9 to 65.2) a(P = 0.004) 8.2 (-6.7 to 23.1) 0.157 15 or 12 weeks 22 53.6 (41.6 to 65.5) a(P = 0.047) 16 31.5 (19.2 to 43.9) a(P < 0.001) 22.1 (8.2 to 35.8) 0.016
Fullness, score out of 100
0 weeks 30 61.6 (51.0 to 72.2) 31 55.1 (40.4 to 69.9) 6.5 (-7.8 to 20.8) 0.478
7 or 6 weeks 28 49.6 (38.1 to 61.2) 28 35.7 (22.2 to 49.1) a(P = 0.025) 13.9 (-0.2 to 28.0) 0.185 15 or 12 weeks 22 41.5 (29.5 to 53.5) a(P = 0.009) 16 24.0 (11.8 to 36.2) a(P < 0.001) 17.5 (3.7 to 31.3) 0.066
Measurement . mIER . mCER groups
Peptide YY, pg/mL
0 weeks 17 82.3 (64.5 to 100.2) 16 61.4 (53.6 to 69.1) 20.9 (0.2 to 41.8) 0.046
12 weeks* - - 11 60.6 (53.2 to 68.1) 30.1 (9.7 to 50.5) 0.034
15 weeks 13 90.7 (73.1 to 108) 11 60.8 (52.5 to 69.2) 29.9 (9.1 to 50.7) 0.050
Irritability, score out of 100
0 weeks 30 11.3 (4.9 to 17.6) 31 13.8 (3.8 to 23.8) -2.5 (-11.7 to 6.7) 0.662
7 or 6 weeks 28 13.7 (7.4 to 20.0) 28 18.1 (8.8 to 27.3) -4.4 (-13.2 to 4.4) 0.482
15 or 12 weeks 22 21.6 (8.0 to 35.2) 16 34.9 (24.0 to 45.9) a(P = 0.006) -13.3 (-27.5 to 0.9) 0.183 Alertness, score out of 100
0 weeks 30 49.5 (41.0 to 58.0) 31 58.6 (45.2 to 71.9) -9.1 (-21.4 to 3.3) 0.248
7 or 6 weeks 28 45.8 (34.2 to 57.4) 28 45.6 (31.1 to 60.0) 0.2 (-14.5 to 14.5) 0.526
15 or 12 weeks 22 47.1 (33.9 to 60.4) 16 36.2 (24.9 to 47.5) a(P = 0.004) 10.9 (-3.3 to 25.1) 0.130 Nausea, score out of 100
0 weeks 30 6.91 (1.19 to 12.63) 31 1.94 (0.37 to 3.51) 4.97 (-0.10 to 10.02) 0.164
7 or 6 weeks 28 8.73 (2.75 to 14.71) 28 10.75 (4.03 to 17.47) a(P =
0.009)
-2.02 (-9.27 to 5.07) 0.310
15 or 12 weeks^ 22 4.59 (1.75 to 7.43) 16 10.44 (4.72 to 16.16) a(P = -5.85 (-10.72 to 0.100
Measurement . mIER . mCER groups
0.011) -0.88)
& = Data are presented as Means (lower limit to upper limit of 95% confidence interval). a = significant difference compared to baseline (P value shown in parentheses). b = P value for the comparison between mIER and mCER, with significance being accepted as P < 0.025 for the co-primary outcomes of fat mass (kg) and fat-free mass (kg), P < 0.05 for all other outcome variables. #97.5% confidence intervals are shown for the co-primary outcomes of fat mass (kg) and fat-free mass (kg) instead of a 95% confidence interval. ^Kruskal-Wallis test was used instead of ANCOVA.
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