Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
- Conditions
- Pharmacokinetics After Oral IntakeSafety After Oral IntakeImmune Cells Activity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: 6-prenylnaringeninDietary Supplement: 8-prenylnaringenin
- Registration Number
- NCT03140397
- Lead Sponsor
- University of Hohenheim
- Brief Summary
The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have known potential biological properties, but poor bioavailability due to their low oral absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake. Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids on the function of cells of the immune system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-45 years
- BMI: 19-25 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Capsules filled with mannitol and silicon dioxide 6-prenylnaringenin 6-prenylnaringenin 500 mg 6-PN plus mannitol and silicon dioxide 8-prenylnaringenin 8-prenylnaringenin 500 mg 8-PN plus mannitol and silicon dioxide
- Primary Outcome Measures
Name Time Method Mean area under the curve (AUC) of plasma concentration vs. time of total 6-prenylnaringenin [nmol/L*h] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total 6-PN after deconjugation with beta-glucuronidase/sulphatase
Cell viability of PBMCs after 6-PN administration 0, 6, and 24 h post dose Time to reach maximum plasma concentration (Tmax) of total 6-prenylnaringenin [h] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Mean area under the curve (AUC) of plasma concentration vs. time of total 8-prenylnaringenin [nmol/L*h] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total 8-prenylnaringenin [nmol/L] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Time to reach maximum plasma concentration (Tmax) of total 8-prenylnaringenin [h] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Cell count (dead cells/ml and living cells/ml) of PBMCs after 8-PN administration 0, 6, and 24 h post dose Cumulative urinary excretion of total 8-prenylnaringenin [nmol/g creatinine] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase
Mean maximum plasma concentration (Cmax) of total 6-prenylnaringenin [nmol/L] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Cumulative urinary excretion of total 6-prenylnaringenin [nmol/g creatinine] 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase
Cell count (dead cells/ml and living cells/ml) of PBMCs after 6-PN administration 0, 6, and 24 h post dose Cell viability of PBMCs after 8-PN administration 0, 6, and 24 h post dose
- Secondary Outcome Measures
Name Time Method Lymphocytes [%] 0, 24h post-dose Mean corpuscular hemoglobin [pg] 0, 24h post-dose Mean corpuscular hemoglobin concentration [g/dL] 0, 24h post-dose Mean corpuscular volume [fL] 0, 24h post-dose Hematocrit [%] 0, 24h post-dose Erythrocytes [/pL] 0, 24h post-dose Leucocytes [/nL] 0, 24h post-dose Serum alanine transaminase activity [U/L] 0, 4, 24h post-dose Serum total cholesterol [mg/dL] 0, 4, 24h post-dose Thrombocytes [/nL] 0, 24h post-dose Serum alkaline phosphatase activity [U/L] 0, 4, 24h post-dose Serum HDL cholesterol [mg/dL] 0, 4, 24h post-dose Serum cystatin C [mg/mL] 0, 4, 24h post-dose Glomerular filtration rate [mL/min] 0, 4, 24h post-dose Serum glucose [mg/dL] 0, 24h post-dose Basophil granulocytes [%] 0, 24h post-dose Serum gamma-glutamyl transferase activity [U/L] 0, 4, 24h post-dose Serum creatinine [mg/dL] 0, 4, 24h post-dose Serum LDL cholesterol [mg/dL] 0, 4, 24h post-dose Serum triacylglycerols [mg/dL] 0, 4, 24h post-dose Monocytes [%] 0, 24h post-dose Serum aspartate transaminase activity [U/L] 0, 4, 24h post-dose Serum bilirubin 0, 4, 24h post-dose Serum uric acid [mg/dL] 0, 4, 24h post-dose LDL/HDL cholesterol ratio 0, 4, 24h post-dose Hemoglobin [g/dL] 0, 24h post-dose Segmented granulocytes [%] 0, 24h post-dose Eosinophil granulocytes [%] 0, 24h post-dose
Trial Locations
- Locations (2)
University of Hohenheim
🇩🇪Stuttgart, Baden-Württemberg, Germany
Eberhard Karls University Tuebingen
🇩🇪Tübingen, Baden-Württemberg, Germany