PBMC Activity After Native vs. Micellar 6-PN Oral Intake Clinical Trial
Official title:
Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization
| NCT number | NCT03286777 |
| Other study ID # | HS-PF2-2017 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 22, 2017 |
| Est. completion date | July 1, 2018 |
| Verified date | October 2018 |
| Source | University of Hohenheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals up to 24 h after intake of the native compound, the micellar formulation or placebo. The safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be investigated.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | July 1, 2018 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Healthy volunteers with blood chemistry values within normal ranges - Age: 18-45 years - BMI: 19-25 kg/m2 Exclusion Criteria: - Pregnancy or lactation - Alcohol and/or drug abuse - Use of dietary supplements or any medications, except contraceptives - Any known malignant, metabolic and endocrine diseases - Previous cardiac infarction - Dementia - Participation in a clinical trial within the past 6 weeks prior to recruitment - Physical activity of more than 5 h/wk |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Hohenheim | Stuttgart | Baden-Württemberg |
| Germany | Eberhard Karls University Tuebingen | Tübingen | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University of Hohenheim | Universität Tübingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean area under the curve (AUC) of plasma concentration vs. time of total 6-PN [nmol/L*h] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose | |
| Primary | Mean maximum plasma concentration (Cmax) of total 6-PN [nmol/L] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose | |
| Primary | Time to reach maximum plasma concentration (Tmax) of total 6-PN [h] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h post dose | |
| Primary | Cumulative urinary excretion of total 6-PN [nmol/g creatinine] | Total 6-PN determined after deconjugation with beta-glucuronidase/sulphatase | 0 h - 24 h post dose | |
| Primary | Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration | 0 h, 6 h, and 24 h post dose | ||
| Primary | Cell viability of PBMCs after 6-PN administration | 0 h, 6 h, and 24 h post dose | ||
| Secondary | Serum aspartate transaminase activity [U/L] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum alanine transaminase activity [U/L] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum gamma-glutamyl transferase activity [U/L] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum alkaline phosphatase activity [U/L] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum bilirubin | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum uric acid [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum creatinine [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum total cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum HDL cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum LDL cholesterol [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum triacylglycerols [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | LDL/HDL cholesterol ratio | 0 h, 4 h, 24h post-dose | ||
| Secondary | Glomerular filtration rate [mL/min] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Serum glucose [mg/dL] | 0 h, 4 h, 24h post-dose | ||
| Secondary | Hemoglobin [g/dL] | 0 h, 24 h post-dose | ||
| Secondary | Mean corpuscular hemoglobin concentration [g/dL] | 0 h, 24 h post-dose | ||
| Secondary | Mean corpuscular hemoglobin [pg] | 0 h, 24 h post-dose | ||
| Secondary | Mean corpuscular volume [fL] | 0 h, 24 h post-dose | ||
| Secondary | Hematocrit [%] | 0 h, 24 h post-dose | ||
| Secondary | Erythrocytes [/pL] | 0 h, 24 h post-dose | ||
| Secondary | Thrombocytes [/nL] | 0 h, 24 h post-dose | ||
| Secondary | Leucocytes [/nL] | 0 h, 24 h post-dose |