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Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

U

University of Hohenheim

Status and phase

Completed
Early Phase 1

Conditions

Safety After Oral Intake
Pharmacokinetics After Oral Intake

Treatments

Dietary Supplement: Vineatrol 30 native powder
Dietary Supplement: Vineatrol 30 micelles

Study type

Interventional

Funder types

Other

Identifiers

NCT02944097
HS-VM-2015

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 2 patient groups

Vineatrol30 native powder
Experimental group
Description:
500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin
Treatment:
Dietary Supplement: Vineatrol 30 native powder
Vineatrol30 micelles
Experimental group
Description:
500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin
Treatment:
Dietary Supplement: Vineatrol 30 micelles

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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