Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects
Table 2
Demographic and baseline characteristics.
Parameter
FAS population
IQP-AE-103 LD ()
IQP-AE-103 HD ()
Placebo ()
Gender
Men
8 (22.9%)
9 (25.7%)
9 (29%)
Women
27 (77.1%)
26 (74.3%)
22 (71%)
Mean age (years)
46.8 ± 12.3
48.7 ± 12.8
46.7 ± 12.2
Age group
18–40 years
9 (25.7%)
9 (25.7%)
11 (35.5%)
41–65 years
26 (74.3%)
26 (74.3%)
20 (64.5%)
Height (cm)
169.5 ± 10.6
168.8 ± 8.9
168.7 ± 11.0
Body weight (kg)
84.42 ± 14.89
84.04 ± 10.56
86.77 ± 15.27
BMI (kg/m2)
29.15 ± 2.17
29.44 ± 2.31
30.25 ± 2.59
Energy requirement (kcal)
2193.7 ± 473.9
2158.7 ± 328.0
2230.2 ± 450.6
Waist circumference (cm)
102.7 ± 10.0
100.9 ± 7.5
104.7 ± 11.4
Hip circumference (cm)
107.1 ± 7.8
106.9 ± 7.1
108.5 ± 6.9
Body fat mass (kg)
30.90 ± 6.81
30.77 ± 6.51
31.44 ± 7.34
Fat-free mass (kg)
53.52 ± 11.98
53.29 ± 9.11
55.33 ± 13.27
All data are presented as mean ± s.d. No significant difference was found between groups for all variables. FAS = full analysis set; LD = low dose; HD = high dose.