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Completed

NCT Number: NCT02944097

Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

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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Key information

Conditions

Safety After Oral Intake Pharmacokinetics After Oral Intake

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vineatrol 30 native powder

Dietary Supplement

Vineatrol 30 micelles

Dietary Supplement

Primary outcomes

  1. Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*h]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase

  2. Mean area under the curve (AUC) of plasma concentration vs. time of total trans-epsilon-viniferin [nmol/L*h]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase

  3. Mean maximum plasma concentration (Cmax) of total trans-resveratrol [nmol/L]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase

  4. Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [nmol/L]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase

  5. Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase

  6. Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase

  7. Cumulative urinary excretion of total trans-resveratrol [nmol/g creatinine]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-resveratrol after deconjugation with beta-glucuronidase/sulphatase

  8. Cumulative urinary excretion of total trans-epsilon-viniferin [nmol/g creatinine]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose

    Total trans-epsilon-viniferin after deconjugation with beta-glucuronidase/sulphatase

Secondary outcomes

  1. Serum aspartate transaminase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  2. Serum alanine transaminase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  3. Serum gamma-glutamyl transferase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  4. Serum alkaline phosphatase activity [U/L]

    Time frame: 0, 4, 24h post-dose

  5. Serum bilirubin

    Time frame: 0, 4, 24h post-dose

  6. Serum uric acid [mg/dL]

    Time frame: 0, 4, 24h post-dose

  7. Serum creatinine [mg/dL]

    Time frame: 0, 4, 24h post-dose

  8. Serum total cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  9. Serum HDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  10. Serum LDL cholesterol [mg/dL]

    Time frame: 0, 4, 24h post-dose

  11. Serum triacylglycerols [mg/dL]

    Time frame: 0, 4, 24h post-dose

  12. LDL/HDL cholesterol ratio

    Time frame: 0, 4, 24h post-dose

  13. Serum cystatin C [mg/mL]

    Time frame: 0, 4, 24h post-dose

  14. Glomerular filtration rate [mL/min]

    Time frame: 0, 4, 24h post-dose

  15. Serum glucose [mg/dL]

    Time frame: 0, 24h post-dose

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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