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Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

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ClinicalTrials.gov Identifier: NCT02944097
Recruitment Status : Completed
First Posted : October 25, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Safety After Oral Intake Pharmacokinetics After Oral Intake Dietary Supplement: Vineatrol 30 native powder Dietary Supplement: Vineatrol 30 micelles Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine Extract
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944097


Locations
Germany
University of Hohenheim
Stuttgart, Baden-Württemberg, Germany, 70599
Sponsors and Collaborators
University of Hohenheim
Investigators
Principal Investigator: Jan Frank, Prof. Dr University of Hohenheim

Additional Information:
Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT02944097     History of Changes
Other Study ID Numbers: HS-VM-2015
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by University of Hohenheim:
Bioavailability
Pharmacokinetics
trans-resveratrol
trans-epsilon-viniferin
Vineatrol 30

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents