Measures (median (IQR)) | Mandolean+ group | Standard care group | Cliff’s delta (C.I.) | ||||
---|---|---|---|---|---|---|---|
Baseline | Post-Intervention | Mean % difference (C.I.)a | Baseline | Post-Intervention | Mean % difference (C.I.)a | (Post-Intervention) | |
N with VAS ratings | 10 | 10 | 10 | 9 | 9 | 9 | |
Fullness rating (0–7 Likert scale) | |||||||
Fasting | 2.00 (2.00) | 3.50 (1.25) | 125.93 (−20.02, 271.87) | 2.00 (1.50) | 3.00 (1.00) | 111.11 (32.40, 189.82) | 0.21 (− 0.28, 0.62) |
Post glucose load: 30 mins. | 2.00 (3.00) | 4.50 (2.50) | b-70.00 (−173.89, 33.89) | 4.00 (2.50) | 3.00 (1.00) | b-96.25 (− 146.22, − 46.28) | b0.27 (−0.24, 0.66) |
60 min | 1.50 (2.25) | 4.00 (1.00) | b − 100.00 (− 248.41, 48.41) | 2.00 (1.50) | 3.00 (2.00) | b − 84.00 (− 189.94, 21.94) | b0.46 (− 0.08, 0.79) |
90 min | 1.00 (2.00) | 5.00 (1.25) | b − 112.50 (− 341.02, 116.02) | 2.00 (3.50) | 4.00 (0.50) | b − 33.33 (− 119.02, 52.35) | b0.52 (0.02, 0.82) |
Hunger rating (0–7 Likert scale) | |||||||
Fasting | 5.00 (3.50) | 1.00 (0.50) | −54.71 (−80.57, − 28.85) | 4.00 (1.50) | 2.00 (2.00) | −32.33 (− 66.60, 2.16) | 0.46 (− 0.78, 0.05) |
Post glucose load: 30 mins. | 4.00 (1.50) | 1.00 (1.00) | b − 106.25 (− 121.03, − 91.47) | 3.00 (2.50) | 1.00 (1.00) | b 45.24 (− 153.10, 243.58) | b0.26 (− 0.30, 0.69) |
60 min | 4.50 (2.75) | 1.00 (0.25) | b − 100.00 (− 153.40, − 46.60) | 3.00 (2.00) | 1.00 (0.50) | b − 58.33 (− 165.44, 4.77) | b0.23 (− 0.33, 0.67) |
90 min | 4.00 (3.00) | 1.00 (1.00) | b − 107.14 (− 148.75, − 65.54) | 4.00 (2.00) | 1.00 (1.00) | b − 71.43 (− 184.25, 41.39) | b0.31 (− 0.26, 0.71) |
Thirst rating (0–7 Likert scale) | |||||||
Fasting | 3.00 (1.50) | 3.00 (2.00) | − 7.59 (− 48.69, 33.51) | 4.00 (2.00) | 2.00 (1.50) | −21.85 (−62.00, 18.30) | 0.31 (− 0.23, 0.70) |
Post glucose load: 30 mins. | 2.00 (1.00) | 2.00 (3.00) | b − 63.33 (− 114.86, − 11.80) | 3.00 (3.00) | 4.00 (3.00) | b − 17.86 (−155.76, 120.04) | b0.58 (− 0.85, − 0.07) |
60 min | 3.00 (1.00) | 2.50 (2.25) | b − 100.00 (− 252.07, 52.07) | 2.00 (2.00) | 3.00 (1.50) | b − 140.48 (− 217.99, − 62.97) | b0.26 (− 0.65, 0.25) |
90 min | 3.00 (1.50) | 2.00 (2.25) | b − 33.33 (− 176.76, 110.09) | 4.00 (2.00) | 2.00 (1.50) | b − 66.67 (− 121.02, − 12.31) | b0.39 (− 0.77, 0.19) |
N with blood plasma data | 5 | 4 | 4 | 5 | 4 | 4 | |
Ghrelin (pg/ml) | |||||||
Fasting | 9.80 (8.25) | 14.00 (9.90) | 69.24 (− 38.24, 176.72) | 14.30 (15.50) | 12.40 (7.50) | 10.49 (−99.79, 120.77) | 0.63 (− 0.38, 0.95) |
Post glucose load: 30 mins. | 8.75 (6.58) | 14.40 (5.50) | − 105.56 (− 271.44, 60.31) | 10.60 (15.30) | 13.70 (15.00) | 94.21 (− 130.27, 318.69) | c0.13 (− 0.67, 0.78) |
60 min | 9.30 (8.20) | 10.50 (4.20) | −13.42 (− 220.46, 193.61) | 6.90 (6.80) | 13.25 (7.80) | −78.25 (− 200.61, 44.11) | c0.75 (− 0.97, 0.21) |
90 min | 7.60 (9.10) | 10.05 (6.60) | −7.08 (− 167.01, 152.87) | 13.30 (17.95) | 10.95 (10.80) | −58.32 (− 237.17, 120.52) | c0.75 (− 0.97, 0.21) |
PYY (pg/ml) | |||||||
Fasting | 79.30 (40.75) | 79.50 (38.60) | −2.29 (−19.81, 15.23) | 63.40 (50.55) | 68.75 (73.3) | 4.75 (−21.19, 30.70) | 0.25 (− 0.61, 0.84) |
Post glucose load: 30 mins. | 81.45 (45.33) | 83.65 (30.90) | − 174.86 (− 511.86, 162.15) | 76.60 (15.95) | 82.50 (35.00) | −10.98 (− 48.89, 26.93) | c0.13 (− 0.80, 0.69) |
60 min | 58.20 (28.90) | 67.90 (29.70) | −32.74 (− 56.14, − 9.34) | 63.20 (23.15) | 60.10 (32.40) | −30.02 (− 264.99, 204.95) | c0.25 (− 0.61, 0.84) |
90 min | 55.00 (21.75) | 62.70 (27.20) | −30.77 (− 79.01, 17.46) | 59.50 (39.20) | 83.45 (48.00) | 745.41 (− 1610.16, 3100.98) | c0.50 (− 0.92, 0.43) |
Glucose | |||||||
Fasting | 6.00 (1.25) | 6.4 (0.5) | 1.22 (− 21.47, 23.92) | 6.24 (0.25) | 6.35 (1.48) | 1.97 (−16.98, 20.91) | 0.06 (− 0.70, 0.76) |
Post glucose load: 30 mins. | 10.00 (3.32) | 9.55 (2.35) | 7.46 (− 64.99, 79.90) | 10.40 (4.95) | 9.05 (3.52) | −87.53 (− 234.61, 59.54) | c0.51 (− 0.43, 0.92) |
60 min | 10.30 (5.20) | 8.45 (1.60) | 19.20 (− 200.77, 239.17) | 7.30 (2.30) | 7.75 (2.03) | −30.16 (− 283.69, 223.36) | c0.94 (0.35, 1.00) |
90 min | 8.40 (0.95) | 8.01 (2.45) | −11.83 (− 118.84, 95.18) | 8.20 (2.35) | 7.3 (2.25) | −104.87 (− 367.08, 157.33) | c0.38 (− 0.52, 0.88) |