Healthy volunteers Not Applicable
Conditions
Interventions
In the 1st and 2nd phases of the study, healthy volunteers will ingest a single dose of Robuvit (500 mg) and provide blood and saliva samples. In the 3rd phase, volunteers will take a daily dose of 30
Sponsors
Horphag Research (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males/females between the age of 18-65 years 2. Will to adhere to dietary limitations during conduction 3. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Severe/uncontrolled diseases of infectious diseases (e.g., hepatitis) 2. Volunteer cannot take or refuses to take Robuvit® for any reason 3. Age under 18 or over 65 years 4. Volunteer belongs to urolithin-nonproducing metabotype 5. Intake of antibiotics within 4 weeks prior to or during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urolithins kinetics after intake of a single dose of Robuvit® and under steady-state conditions analysed with a liquid chromatography system with a triple quadrupole mass spectrometer detector (LC-MS). The times of serum and saliva sampling in phase 2 will be at t = 0, 6, 8, 10, 12, 24, 30, 48, 54, 72 and 78 hours. If the blue gut transit time indicator is not detected in stool after 4 days, the measurement period may be extended by one day (to 96 or 102 hours). In phase 3, saliva sampling will be conducted as in phase 2, while serum sampling will be limited to time points t = 0, 6, 10, 24, 30, 48, 54, 72, and 78 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation analysis: The kinetic profiles of urolithins in serum and saliva measured using LC-MS at different timepoints (t = 0, 6, 8, 10, 12, 24, 30, 48, 54, 72 and 78 hours), and gut transit time assessed by monitoring the presence of blue color in stool after ingesting a blue food dye as a visual marker 1 hour after consuming Robuvit® (individually from hours to days) 2. The levels of urolithins in saliva and blood serum compartments measured by LC-MS at 24 hours after a single dose of Robuvit® to assess the suitability of using saliva for metabotype screening | — |
Countries
Slovakia
Contacts
Public ContactZuzana Paduchova
Outcome results
None listed