NCT02944097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

October 24, 2016

Last Update Submit

May 2, 2017

Conditions

Safety After Oral IntakePharmacokinetics After Oral Intake

Keywords

BioavailabilityPharmacokineticstrans-resveratroltrans-epsilon-viniferinVineatrol 30

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (15)

  • Serum aspartate transaminase activity [U/L]

    0, 4, 24h post-dose

  • Serum alanine transaminase activity [U/L]

    0, 4, 24h post-dose

  • Serum gamma-glutamyl transferase activity [U/L]

    0, 4, 24h post-dose

  • Serum alkaline phosphatase activity [U/L]

    0, 4, 24h post-dose

  • Serum bilirubin

    0, 4, 24h post-dose

  • +10 more secondary outcomes

Study Arms (2)

Vineatrol30 native powder

EXPERIMENTAL

500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin

Dietary Supplement: Vineatrol 30 native powder

Vineatrol30 micelles

EXPERIMENTAL

500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin

Dietary Supplement: Vineatrol 30 micelles

Interventions

Vineatrol 30 native powderDIETARY_SUPPLEMENT
Vineatrol30 native powder
Vineatrol 30 micellesDIETARY_SUPPLEMENT
Vineatrol30 micelles

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Volunteers with blood chemistry values within normal ranges
  • Age: 18-35 years
  • BMI: 19-25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

Related Links

Study Officials

  • Jan Frank, Prof. Dr

    University of Hohenheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 25, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

February 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

DE(1)