Bioavailability and Pharmacokinetics, Safety After Oral Intake
Conditions
Keywords
chrysin, pharmacokinetics, bioavailability, micellar delivery, natural health products, caco-2 permeability, safety, dietary supplements
Brief summary
This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. The study also seeks to determine the short-term effects and safety of daily oral supplementation of LipoMicel Chrysin in healthy adult volunteers over a 30-day study period.
Interventions
DIETARY_SUPPLEMENTLipoMicel Chrysin
A maximum single oral dose of 1000 mg chrysin
DIETARY_SUPPLEMENTNon-Micellar Chrysin
A maximum single oral dose of 1000 mg chrysin
DIETARY_SUPPLEMENTStandard/Unformulated Chrysin
A maximum single oral dose of 1000 mg chrysin
Sponsors
Isura
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of LipoMicel Chrysin intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female aged 21-65 years * healthy, good physical condition * voluntary, written, informed consent to participate in the study.
Exclusion criteria
* use of anti-inflammatory or non-steroidal anti-inflammatory drugs * previous history of cardiovascular disease or acute or chronic inflammatory disease * use of antioxidant or polyphenol supplements or cholesterol-lowering agents * change of diet habits or lifestyle (diet, physical activity, etc.) * alcohol or substance abuse history * use of nicotine or tobacco * participation in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)] | To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing chrysin. |
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)] | To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing chrysin. |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)] | To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in kidney function based on serum creatinine. |
| Glomerular filtration rate (GFR) | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in kidney function based on GFR. |
| Fasting blood glucose | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in blood glucose levels based on fasting blood glucose. |
| HbA1c | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in blood glucose levels based on HbA1c. |
| Alanine aminotransferase (ALT) | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in liver function based on ALT. |
| Triglycerides | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)] | To evaluate changes in lipid profile based on triglycerides. |
| Low-density lipoprotein (LDL) cholesterol | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)] | To evaluate changes in lipid profile based on LDL. |
| High-density lipoprotein (HDL) cholesterol | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)] | To evaluate changes in lipid profile based on HDL. |
| Total cholesterol | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)] | To evaluate changes in lipid profile based on total cholesterol. |
| Aspartate aminotransferase (AST) | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in liver function based on AST. |
| Total bilirubin (TB) | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] | To evaluate changes in liver function based on total bilirubin. |
Countries
Canada
Outcome results
None listed