Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

Pharmacokinetics After Oral Intake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944097
• Other study ID #: HS-VM-2015
• Status: Completed
• Phase: Early Phase 1
• First received: October 24, 2016
• Last updated: May 2, 2017
• Start date: March 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics After Oral Intake
• Safety After Oral Intake

Intervention

Dietary Supplement:
• Vineatrol 30 native powder

• Vineatrol 30 micelles

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Serum aspartate transaminase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum alanine transaminase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum gamma-glutamyl transferase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum alkaline phosphatase activity [U/L]		0, 4, 24h post-dose
Secondary	Serum bilirubin		0, 4, 24h post-dose
Secondary	Serum uric acid [mg/dL]		0, 4, 24h post-dose
Secondary	Serum creatinine [mg/dL]		0, 4, 24h post-dose
Secondary	Serum total cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum HDL cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum LDL cholesterol [mg/dL]		0, 4, 24h post-dose
Secondary	Serum triacylglycerols [mg/dL]		0, 4, 24h post-dose
Secondary	LDL/HDL cholesterol ratio		0, 4, 24h post-dose
Secondary	Serum cystatin C [mg/mL]		0, 4, 24h post-dose
Secondary	Glomerular filtration rate [mL/min]		0, 4, 24h post-dose
Secondary	Serum glucose [mg/dL]		0, 24h post-dose

External Links

•   Website of the research group