Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles
- Conditions
- Pharmacokinetics After Oral IntakeSafety After Oral Intake
- Interventions
- Dietary Supplement: Vineatrol 30 native powderDietary Supplement: Vineatrol 30 micelles
- Registration Number
- NCT02944097
- Lead Sponsor
- University of Hohenheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Healthy Volunteers with blood chemistry values within normal ranges
Age: 18-35 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
Smoking
Physical activity of more than 5 h/wk
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Vineatrol30 native powder Vineatrol 30 native powder 500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin Vineatrol30 micelles Vineatrol 30 micelles 500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin
- Primary Outcome Measures
Name Time Method 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
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
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-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
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 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
- Secondary Outcome Measures
Name Time Method Serum cystatin C [mg/mL] 0, 4, 24h post-dose Serum aspartate 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 LDL/HDL cholesterol ratio 0, 4, 24h post-dose Serum total cholesterol [mg/dL] 0, 4, 24h post-dose Glomerular filtration rate [mL/min] 0, 4, 24h post-dose Serum glucose [mg/dL] 0, 24h post-dose Serum alanine transaminase activity [U/L] 0, 4, 24h post-dose Serum creatinine [mg/dL] 0, 4, 24h post-dose Serum triacylglycerols [mg/dL] 0, 4, 24h post-dose Serum bilirubin 0, 4, 24h post-dose Serum uric acid [mg/dL] 0, 4, 24h post-dose Serum HDL cholesterol [mg/dL] 0, 4, 24h post-dose Serum LDL cholesterol [mg/dL] 0, 4, 24h post-dose
Trial Locations
- Locations (1)
University of Hohenheim
🇩🇪Stuttgart, Baden-Württemberg, Germany