Pharmacokinetics After Oral Intake, Safety After Oral Intake
Conditions
Keywords
Bioavailability, Pharmacokinetics, trans-resveratrol, trans-epsilon-viniferin, Vineatrol 30
Brief summary
To enhance the oral bioavailability of the antioxidants trans-resveratrol and trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was incorporated into micelles. A single dose, single blind, two arms crossover trial was conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and compared between formulations. Tolerability of the dose was also controlled by safety parameters in plasma.
Interventions
DIETARY_SUPPLEMENTVineatrol 30 native powder
DIETARY_SUPPLEMENTVineatrol 30 micelles
Sponsors
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers with blood chemistry values within normal ranges Age: 18-35 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 Smoking Physical activity of more than 5 h/wk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*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 trans-epsilon-viniferin [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 trans-resveratrol [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase |
| Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [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 trans-resveratrol [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase |
| Cumulative urinary excretion of total trans-resveratrol [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 |
| Cumulative urinary excretion of total trans-epsilon-viniferin [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 |
Secondary
| Measure | Time frame |
|---|---|
| Serum HDL cholesterol [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 |
| Serum aspartate transaminase activity [U/L] | 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 |
| LDL/HDL cholesterol ratio | 0, 4, 24h post-dose |
| Serum alanine transaminase activity [U/L] | 0, 4, 24h post-dose |
| Serum gamma-glutamyl transferase activity [U/L] | 0, 4, 24h post-dose |
| Serum alkaline phosphatase 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 |
| Serum creatinine [mg/dL] | 0, 4, 24h post-dose |
| Serum total cholesterol [mg/dL] | 0, 4, 24h post-dose |
Countries
Germany
Outcome results
None listed