Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Creatinine (24 h urine) |
Creatinine (mmol/l) |
change from baseline after 16 weeks |
|
Other |
Albumine (24 h urine) |
Albumine (mg/l) |
change from baseline after 16 weeks |
|
Other |
Selenium (24 h urine) |
Selenium (µmol/24 h) |
change from baseline after 16 weeks |
|
Other |
Zinc (24 h urine) |
Zinc (µmol/24 h) |
change from baseline after 16 weeks |
|
Primary |
Body weight |
Body weight (kg) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Body fat |
Body fat (%) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Systolic blood pressure |
systolic pressure (mm Hg) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Diastolic blood pressure |
diastolic blood pressure (mm Hg) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Basal metabolic rate |
Basal metabolic rate (kcal per day) - measurement: indirect calorimetry |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Total cholesterol (plasma) |
Total cholesterol (mmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
LDL cholesterol (plasma) |
LDL cholesterol (mmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
HDL cholesterol (plasma) |
HDL cholesterol (mmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Triacylglycerides (plasma) |
Triacylglycerides (mmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Glucose (fasting) (serum) |
Glucose (mmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Insulin (fasting) (serum) |
Insulin (mU/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
HbA1c (serum) |
HbA1c (%) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
alpha prothrombin time (serum) |
alpha prothrombin time (s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Fibrinogen (serum) |
Fibrinogen (g/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
High sensitive c-reactive protein (plasma) |
High sensitive c-reactive protein (mg/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Homocysteine (serum) |
Homocysteine (µmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Triiodothyronine (plasma) |
Triiodothyronine fT3 (pmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Thyroxine (plasma) |
Thyroxine fT4 (pmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Thyroid-stimulating hormone (plasma) |
Thyroid-stimulating hormone (mU/l) |
change from baseline after 16 weeks |
|
Secondary |
Parathyroid hormone (plasma) |
Parathyroid hormone (ng/l) |
change from baseline after 16 weeks |
|
Secondary |
Alkaline phosphatase (serum) |
Alkaline phosphatase (µg/l) |
change from baseline after 16 weeks |
|
Secondary |
Osteocalcin (serum) |
Osteocalcin (ng/ml) |
change from baseline after 16 weeks |
|
Secondary |
Uric acid (plasma) |
Uric acid (µmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Alanine aminotransferase (plasma) |
Alanine aminotransferase (µmol/l*s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Aspartate transaminase (plasma) |
Aspartate transaminase (µmol/l*s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Cholinesterase (plasma) |
Cholinesterase (µmol/l*s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Gamma-glutamyltransferase (plasma) |
Gamma-glutamyltransferase (µmol/l*s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Lactate dehydrogenase (plasma) |
Lactate dehydrogenase (µmol/l*s) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Fatty acid distribution in plasma lipids (plasma) |
Fatty acid distribution in plasma lipids (% fatty acid methyl esters) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Fatty acid distribution in erythrocyte lipids (erythrocytes) |
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Vitamin A (serum) |
Vitamin A (mmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin D (plasma) |
Vitamin D (nmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin E (serum) |
Vitamin E (µmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin B1 (serum) |
Vitamin B1 (nmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin B2 (serum) |
Vitamin B2 (nmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin B6 (serum) |
Vitamin B6 (nmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin B12 (plasma) |
Vitamin B12 (pmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Holo-transcobalamin (plasma) |
Holo-transcobalamin (pmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Folic acid (plasma) |
Folic acid (µg/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin H (serum) |
Vitamin H (ng/l) |
change from baseline after 16 weeks |
|
Secondary |
Vitamin C (plasma) |
Vitamin C (mg/l) |
change from baseline after 16 weeks |
|
Secondary |
Calcium (plasma) |
Calcium (mmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Potassium (plasma) |
Potassium (mmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Iron (plasma) |
Iron (µmol/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Ferritin (plasma) |
Ferritin (µg/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Transferrin (plasma) |
Transferrin (g/l) |
change from baseline after 4, 8, 12, 16 weeks |
|
Secondary |
Iodine (serum) |
Iodine (µmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Selenium (serum) |
Selenium (µmol/l) |
change from baseline after 16 weeks |
|
Secondary |
Zinc (serum) |
Zinc (µmol/l) |
change from baseline after 16 weeks |
|