Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine Extract

Conditions
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Safety After Oral Intake, Pharmacokinetics After Oral Intake

Intervention / Treatment
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* Dietary Supplement: Vineatrol 30 native powder
* Dietary Supplement: Vineatrol 30 micelles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vineatrol30 native powder<br>500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin | Dietary Supplement: Vineatrol 30 native powder<br> <br> |
| Experimental: Vineatrol30 micelles<br>500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin | Dietary Supplement: Vineatrol 30 micelles<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*h] | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Mean area under the curve (AUC) of plasma concentration vs. time of total trans-epsilon-viniferin [nmol/L*h] | Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Mean maximum plasma concentration (Cmax) of total trans-resveratrol [nmol/L] | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [nmol/L] | Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h] | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h] | Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Cumulative urinary excretion of total trans-resveratrol [nmol/g creatinine] | Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 
| Cumulative urinary excretion of total trans-epsilon-viniferin [nmol/g creatinine] | Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum aspartate transaminase activity [U/L] |  | 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 | 
| 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 | 
| LDL/HDL cholesterol ratio |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Pharmacokinetics, trans-resveratrol, trans-epsilon-viniferin, Vineatrol 30