Clinical Study

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 5

Summary of changes in laboratory measurements during the study.

MeasurementsPre- to poststudy changes
Low-dose IQP-AE-103 (mean ± s.d.)High-dose IQP-AE-10 (mean ± s.d.)Placebo (mean ± s.d.) value

Hemoglobin (mmol/l)−0.08 ± 0.480.09 ± 0.63−0.04 ± 0.75NS
Hematocrit (l/l)−0.003 ± 0.029−0.003 ± 0.028−0.001 ± 0.036NS
Erythrocytes (Tpt/l)0.01 ± 0.310.02 ± 0.34 −0.02 ± 0.38NS
Thrombocytes (Gpt/l)8.6 ± 40.52.3 ± 42.10.8 ± 56.7NS
Leukocytes (Gpt/l)0.08 ± 1.55−0.33 ± 1.650.16 ± 1.63NS
Mean cell volume (fl)−0.5 ± 3.5−1.2 ± 5.40.1 ± 3.8NS
Mean corpuscular hemoglobin (fmol/Ery)−0.021 ± 0.0580.013 ± 0.0820.001 ± 0.076NS
Mean corpuscular hemoglobin concentration (mmol/l)−0.09 ± 0.950.24 ± 0.870.03 ± 0.96NS
Alanine aminotransferase (μkat/l)−0.075 ± 0.168−0.035 ± 0.2040.004 ± 0.211NS
Aspartate aminotransferase (μkat/l)−0.172 ± 0.483−0.137 ± 0.5660.028 ± 0.174NS
Alkaline phosphatase (μkat/l)0.026 ± 0.194−0.150 ± 0.5220.055 ± 0.305NS
γ-Glutamyl transferase (μkat/l)−0.083 ± 0.205−0.042 ± 0.1610.052 ± 0.346NS
Bilirubin (μmol/l)0.02 ± 6.764.35 ± 9.151.19 ± 7.89NS
Creatinine (mmol/l)0.26 ± 13.583.98 ± 9.371.92 ± 12.17NS
Urea (mmol/l)−0.17 ± 1.440.07 ± 1.24−0.19 ± 1.32NS
Uric acid (μmol/l)−1.8 ± 60.9−6.4 ± 77.311.7 ± 67.2NS
Glucose (mmol/l)−0.01 ± 0.630.01 ± 0.92−0.16 ± 0.54NS
Vitamin A (mg/l)−0.002 ± 0.1490.020 ± 0.1730.063 ± 0.142NS
Vitamin D (ng/l)3.51 ± 13.454.37 ± 10.413.66 ± 11.79NS
Vitamin E (mg/l)−0.81 ± 3.11−0.61 ± 3.071.09 ± 3.78NS
Vitamin K (μg/l)0.013 ± 1.1970.086 ± 0.6900.050 ± 0.689NS
Vitamin K2mK4 (μg/l)−0.002 ± 0.152−0.022 ± 0.154−0.031 ± 0.114NS
Vitamin K2mK7 (μg/l)0.143 ± 0.402−0.157 ± 1.942−0.086 ± 0.507NS
Total cholesterol (mmol/l)−0.08 ± 0.84−0.30 ± 1.120.18 ± 1.09NS
High-density lipoprotein cholesterol (mmol/l)0.00 ± 0.390.10 ± 0.320.02 ± 0.39NS
Low-density lipoprotein cholesterol (mmol/l)−0.02 ± 0.77−0.34 ± 1.040.03 ± 0.86NS
Triglycerides (mmol/l)0.00 ± 0.79−0.09 ± 0.760.13 ± 0.39NS
HbA1c (%)0.14 ± 0.350.03 ± 0.340.11 ± 0.20NS

Values from the Kruskal–Wallis test.