The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive effects in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
1 tablet in the morning
1 tablet in the morning
analyze & realize GmbH
Berlin, Germany
Change in EndoPAT (chronic effect)
Pre-dose at the end vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Change in EndoPAT (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in ex vivo blood platelet aggregation / adhesion (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in ex vivo blood platelet aggregation / adhesion pre-dose (chronic effect)
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in blood coagulation / clotting parameters (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in blood coagulation / clotting parameters predose (chronic effect)
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Global evaluation of benefit
Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)
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Time frame: 12 weeks
Changes in SF- 12
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Physical examination
End of each intervention vs. screening (Week 4 vs. screening, week 12 vs. screening) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Pulse rate
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Systolic Blood Pressure
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Diastolic Blood Pressure
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Assessment of Adverse Events
Start and end of each intervention (Week 0, week 4, week 8 and week 12) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Global assessment of tolerability
Assessed by the subjects and investigator (4-point categorical scale) at week 4 and week 12
Time frame: 12 weeks