Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-02-28

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.

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Detailed Description

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Conditions

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Safety After Oral Intake Pharmacokinetics After Oral Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Vineatrol30 native powder

500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin

Group Type EXPERIMENTAL

Vineatrol 30 native powder

Intervention Type DIETARY_SUPPLEMENT

Vineatrol30 micelles

500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin

Group Type EXPERIMENTAL

Vineatrol 30 micelles

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vineatrol 30 native powder

Intervention Type DIETARY_SUPPLEMENT

Vineatrol 30 micelles

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes