Safety After Oral IntakeEarly Phase 1NCT02944097
Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles
A Early Phase 1 study testing Vineatrol 30 native powder and Vineatrol 30 micelles in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety After Oral Intake, Pharmacokinetics After Oral Intake
- What is being tested?
- Vineatrol 30 native powder and Vineatrol 30 micelles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Feb 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-35 years
- BMI: 19-25 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- Participation in a clinical trial within the past 6 weeks prior to recruitment
- Smoking
- Physical activity of more than 5 h/wk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine Extract
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.
- Being tested
- Vineatrol 30 native powder, Vineatrol 30 micelles
- Keywords
- Bioavailability, Pharmacokinetics, trans-resveratrol, trans-epsilon-viniferin, Vineatrol 30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vineatrol 30 native powderDietary supplement
Vineatrol 30 micellesDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vineatrol30 native powder | Experimental | 500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin Receives: 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 Receives: Dietary Supplement: Vineatrol 30 micelles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post dose
Secondary outcomes (15)
Serum aspartate transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Measured: 0, 4, 24h post-dose
Serum bilirubin
Measured: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Measured: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Measured: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Measured: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Measured: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Measured: 0, 4, 24h post-dose
Serum cystatin C [mg/mL]
Measured: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Measured: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Measured: 0, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety After Oral IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Frank, Prof. Dr, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944097
- Sponsor's protocol ID
- HS-VM-2015
- Status last verified
- May 2017
- First submitted
- 24 Oct 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Oral Bioavailability of Trans-epsilon-viniferin and Trans-resveratrol From Native and Micellar Solubilized vineatrol30 Vine Extract
- ClinicalTrials.gov ID
- NCT02944097
- Acronym / sponsor ID
- HS-VM-2015
- Keywords
- Bioavailability, Pharmacokinetics, trans-resveratrol, trans-epsilon-viniferin, Vineatrol 30
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vineatrol30 native powder | Experimental | Dietary Supplement: Vineatrol 30 native powder500 mg Vineatrol30 containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin |
| Vineatrol30 micelles | Experimental | Dietary Supplement: Vineatrol 30 micelles500 mg Vineatrol30 micelles containing 30 mg trans-resveratrol and 75.2 mg trans-epsilon-viniferin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers with blood chemistry values within normal ranges
- Age: 18-35 years
- BMI: 19-25 kg/m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vineatrol 30 native powder | Dietary supplement | Vineatrol30 native powder |
| Vineatrol 30 micelles | Dietary supplement | Vineatrol30 micelles |
Primary outcome
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
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
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
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
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
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
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
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
15 secondary outcomes
Serum aspartate transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alanine transaminase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum gamma-glutamyl transferase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum alkaline phosphatase activity [U/L]
Time frame: 0, 4, 24h post-dose
Serum bilirubin
Time frame: 0, 4, 24h post-dose
Serum uric acid [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum creatinine [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum total cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum HDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum LDL cholesterol [mg/dL]
Time frame: 0, 4, 24h post-dose
Serum triacylglycerols [mg/dL]
Time frame: 0, 4, 24h post-dose
LDL/HDL cholesterol ratio
Time frame: 0, 4, 24h post-dose
Serum cystatin C [mg/mL]
Time frame: 0, 4, 24h post-dose
Glomerular filtration rate [mL/min]
Time frame: 0, 4, 24h post-dose
Serum glucose [mg/dL]
Time frame: 0, 24h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Website of the research groupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Frank, Prof. Dr principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vineatrol 30 native powder and Vineatrol 30 micelles in people with Safety After Oral Intake and Pharmacokinetics After Oral Intake, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.