Cardiovascular DiseasesNCT01533857
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
A study testing hot water and Black tea and phenolic acids in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
Trial summary
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- hot water and Black tea and phenolic acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Nov 2012
- Phase
- Interventional
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males
- not smoking
Who cannot join
- use of NSAIDS and/or antibiotics
- no blood donation 1 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.
- Conditions
- Cardiovascular Diseases
- Being tested
- hot water, Black tea and phenolic acids
- Keywords
- Black tea, phenolic acids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot waterDietary supplement
Hot water and placebo capsule
Black tea and phenolic acidsDietary supplement
Black tea extract and capsule with phenolic acids
| Study group | Role | What they receive |
|---|---|---|
| Black tea | Experimental | black tea Receives: Dietary Supplement: Black tea and phenolic acids |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: hot water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of selected phenolic acids
Measured: up to 30 hrs
Secondary outcomes (2)
plasma concentration of selected flavonoid metabolites
Measured: up to 30 hrs
Identification of unknown phenolic acids (metabolites of black tea) in plasma
It is still largely unknown which metabolites are formed in-vivo after black tea ingestions and circulating in human plasma. Untargeted profiling using LC-MS of plasma samples will be used to identify yet unknown polyphenols / phenolics and their conjugates in plasma and thus extent the hit-list of known metabolites in circulation after black tea consumption
Measured: up to 30 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, MD, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533857
- Sponsor's protocol ID
- FDS-BNH-0379
- Status last verified
- Nov 2012
- First submitted
- 5 Feb 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.
PubMed 24673575
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
- ClinicalTrials.gov ID
- NCT01533857
- Acronym / sponsor ID
- FDS-BNH-0379
- Conditions
- Cardiovascular Diseases
- Keywords
- Black tea, phenolic acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Feb 2012 (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.
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black tea | Experimental | Dietary Supplement: Black tea and phenolic acidsblack tea |
| placebo | Placebo comparator | Dietary Supplement: hot water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy males
- not smoking
Key exclusion criteria (2 listed)
- use of NSAIDS and/or antibiotics
- no blood donation 1 months prior to screening
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 |
|---|---|---|
| hot waterHot water and placebo capsule | Dietary supplement | placebo |
| Black tea and phenolic acidsBlack tea extract and capsule with phenolic acids | Dietary supplement | Black tea |
Primary outcome
Plasma concentrations of selected phenolic acids
Time frame: up to 30 hrs
2 secondary outcomes
plasma concentration of selected flavonoid metabolites
Time frame: up to 30 hrs
Identification of unknown phenolic acids (metabolites of black tea) in plasma
Time frame: up to 30 hrs
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 13 Aug 2013.
- Derived from this study: PubMed 24673575van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Yves Donazzolo, MD principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot water and Black tea and phenolic acids in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
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 2 inclusion and 2 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 13 Aug 2013. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Plasma concentrations of selected phenolic acids (time frame: up to 30 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533857, which also lists 1 linked publication.
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 13 Aug 2013.