Primary Outcome Measures: | |
1. |
Blood cellular NAD+ concentration in serum [ Time Frame: Day 2 ]
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study |
2. |
Blood cellular NAD+ concentration in serum [ Time Frame: Day 30 ]
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study |
3. |
Blood cellular NAD+ concentration in serum [ Time Frame: Day 60 ]
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study |
4. |
Blood cellular NADH concentration in serum [ Time Frame: Day 2 ]
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study |
5. |
Blood cellular NADH concentration in serum [ Time Frame: Day 30 ]
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study |
6. |
Blood cellular NADH concentration in serum [ Time Frame: Day 60 ]
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study |
7. |
Six minutes walking endurance test [ Time Frame: Day 2 ]
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study |
8. |
Six minutes walking endurance test [ Time Frame: Day 30 ]
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study |
9. |
Six minutes walking endurance test [ Time Frame: Day 60 ]
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study |
10. |
Systolic [ Time Frame: Day 2 ]
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study |
11. |
Systolic [ Time Frame: Day 30 ]
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study |
12. |
Systolic [ Time Frame: Day 60 ]
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study |
13. |
Diastolic blood pressure [ Time Frame: Day 2 ]
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study |
14. |
Diastolic blood pressure [ Time Frame: Day 30 ]
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study |
15. |
Diastolic blood pressure [ Time Frame: Day 60 ]
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study |
16. |
Pulse pressure [ Time Frame: Day 2 ]
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study |
17. |
Pulse pressure [ Time Frame: Day 30 ]
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study |
18. |
Pulse pressure [ Time Frame: Day 60 ]
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study |
19. |
SF-36 questionnaire [ Time Frame: Day 2 ]
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study |
20. |
SF-36 questionnaire [ Time Frame: Day 30 ]
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study |
21. |
SF-36 questionnaire [ Time Frame: Day 60 ]
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study |
Secondary Outcome Measures: | |
1. |
Adverse events [ Time Frame: Day 2 ]
Evaluation of Adverse events |
2. |
Adverse events [ Time Frame: Day 30 ]
Evaluation of Adverse events |
3. |
Adverse events [ Time Frame: Day 60 ]
Evaluation of Adverse events |
4. |
Laboratory parameter (blood chemistry) [ Time Frame: Day 1 ]
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study |
5. |
Laboratory parameter (blood chemistry) [ Time Frame: Day 30 ]
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study |
6. |
Laboratory parameter (blood chemistry) [ Time Frame: Day 60 ]
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study |
7. |
Laboratory parameter (lipid profile) [ Time Frame: Day 1 ]
Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study |
8. |
Laboratory parameter (lipid profile) [ Time Frame: Day 30 ]
Evaluation of Laboratory parameter (blood chemistry, lipid profile, LFT and RFT) changes from baseline to end of the study |
9. |
Laboratory parameter (lipid profile) [ Time Frame: Day 60 ]
Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study |
10. |
Laboratory parameter (LFT ) [ Time Frame: Day 1 ]
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study |
11. |
Laboratory parameter (LFT) [ Time Frame: Day 30 ]
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study |
12. |
Laboratory parameter (LFT) [ Time Frame: Day 60 ]
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study |
13. |
Laboratory parameter (RFT) [ Time Frame: Day 1 ]
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study |
14. |
Laboratory parameter (RFT) [ Time Frame: Day 30 ]
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study |
15. |
Laboratory parameter (RFT) [ Time Frame: Day 60 ]
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study |
16. |
Drop out due to adverse events [ Time Frame: Day 2 ]
Number of participants that dropout due to adverse events including lab values |
17. |
Drop out due to adverse events [ Time Frame: Day 30 ]
Number of participants that dropout due to adverse events including lab values |
18. |
Drop out due to adverse events [ Time Frame: Day 60 ]
Number of participants that dropout due to adverse events including lab values |
Other Outcome Measures: | |
1. |
BMI [ Time Frame: Day 1 ]
Monitoring of BMI inter group comparison from baseline to the end of study |
2. |
BMI [ Time Frame: Day 2 ]
Monitoring of BMI inter group comparison from baseline to the end of study |
3. |
BMI [ Time Frame: Day 30 ]
Monitoring of BMI inter group comparison from baseline to the end of study |
4. |
BMI [ Time Frame: Day 60 ]
Monitoring of BMI inter group comparison from baseline to the end of study |
5. |
HOMA [ Time Frame: Day 2 ]
Monitoring of HOMA inter group comparison from baseline to the end of study |
6. |
HOMA [ Time Frame: Day 60 ]
Monitoring of HOMA inter group comparison from baseline to the end of study |