Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

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

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.

Study Overview

• Status: Completed
• Conditions: Safety After Oral Intake; Pharmacokinetics After Oral Intake
• Intervention / Treatment: Dietary supplement: Vineatrol 30 native powder; Dietary supplement: Vineatrol 30 micelles

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vineatrol30 native powder; 500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin	Dietary supplement: Vineatrol 30 native powder
EXPERIMENTAL: Vineatrol30 micelles; 500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin	Dietary supplement: Vineatrol 30 micelles

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Jan Frank, Prof. Dr, University of Hohenheim

Publications and helpful links

Helpful Links

• Website of the research group

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (ESTIMATE): October 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioavailability; trans-resveratrol; trans-epsilon-viniferin; Vineatrol 30
• Other Study ID Numbers: HS-VM-2015