Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in mean heart rate |
Change in mean heart rate (bpm) during constant load cycling exercise (30 minute submaximal cycle test). Heart rate will be measured every minute during the cycle test at all visits. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Compliance |
Daily dietary diary |
up 12 weeks |
|
Secondary |
Change in Indirect calorimetry |
Oxidation rates measured via indirect calorimetry during constant load cycling Measured at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in self-rated daily function scores |
Modified SF-36 questionnaire |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in self-rated fatigue |
Fatigue Severity Scale score |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in blood ketones |
Ketone bodies in the blood (hydroxybutyrate+acetoacetate umol/L). |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in perceived exertion |
Borg scale (scale from 6-20). During the constant load cyclinging test, subjects will be asked every minute during. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in ammonia |
Blood Ammonia (umol/L). Will be measured 5 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in insulin |
Blood Insulin (pmol/l). Will be measured 6 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in Adrenalin |
Blood Adrenalin (pg/mL) Will be measured 6 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in glucagon |
Blood Glucagon (pmol/L). Will be measured 4 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in maximal oxygen capacity |
(VO2max, mL oxgen per minute) after the 30 minutes submaximal exercise test, the workload will be increased in a step vise manner to maximum. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in maximal work load |
Work load (watts) after the 30 minutes submaximal exercise test, the workload will be increased in a step vise manner to maximum. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in free fatty acids |
Blood Free fatty acids (umol/L). Will be measured 6 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in lactate |
Blood Lactate (mM). Will be measured 6 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|
Secondary |
Change in glucose |
Blood glucose (mM). Will be measured 6 times during the cycle test at visit 1-4. |
At Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks), and Visit 4 (12 weeks) |
|