Clinical trial NCT02944097: Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles
Official title: Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Safety After Oral Intake
Pharmacokinetics After Oral Intake
Keywords: Bioavailability
Pharmacokinetics
trans-resveratrol
trans-epsilon-viniferin
Vineatrol 30
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total trans-resveratrol [nmol/L*h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total trans-epsilon-viniferin [nmol/L*h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Mean maximum plasma concentration (Cmax) of total trans-resveratrol [nmol/L]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Mean maximum plasma concentration (Cmax) of total trans-epsilon-viniferin [nmol/L]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Time to reach maximum plasma concentration (Tmax) of total trans-resveratrol [h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Time to reach maximum plasma concentration (Tmax) of total trans-epsilon-viniferin [h]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Cumulative urinary excretion of total trans-resveratrol [nmol/g creatinine]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
measure: Cumulative urinary excretion of total trans-epsilon-viniferin [nmol/g creatinine]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Secondary outcomes:
measure: Serum aspartate transaminase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum alanine transaminase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum gamma-glutamyl transferase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum alkaline phosphatase activity [U/L]
timeFrame: 0, 4, 24h post-dose
measure: Serum bilirubin
timeFrame: 0, 4, 24h post-dose
measure: Serum uric acid [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum creatinine [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum total cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum HDL cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum LDL cholesterol [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: Serum triacylglycerols [mg/dL]
timeFrame: 0, 4, 24h post-dose
measure: LDL/HDL cholesterol ratio
timeFrame: 0, 4, 24h post-dose
measure: Serum cystatin C [mg/mL]
timeFrame: 0, 4, 24h post-dose
measure: Glomerular filtration rate [mL/min]
timeFrame: 0, 4, 24h post-dose
measure: Serum glucose [mg/dL]
timeFrame: 0, 24h post-dose
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Jan Frank, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: