Cardiovascular DiseasesNCT01662232
Improvement of Endothelial Function by EGCG
A study testing Green tea beverage, Green tea extract and EGCG in people with Cardiovascular Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Green tea beverage, Green tea extract and EGCG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Sep 2013
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteers
- 20-50 years
- BMI < 27 kg/m2
- Cholesterol < 240 mg/dl
Who cannot join
- Diabetes mellitus
- Hypertension
- Conditions with impaired endothelial function
- Smoking
- Regular drug use
- Alcohol abuse
- Regular tea drinkers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin
Berlin, State of Berlin, 10117
About this study
Official title: The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers
Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.
Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.
In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.
- Conditions
- Cardiovascular Diseases
- Being tested
- Green tea beverage, Green tea extract, EGCG, Placebo
- Keywords
- Green tea, EGCG, Cardiovascular diseases, Endothelial function, Flow-mediated dilation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea beverageDietary supplement
Green tea extractDietary supplement
EGCGDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Green tea beverage | Active comparator | 200 mg EGCG as green tea beverage. Receives: Dietary Supplement: Green tea beverage |
| Green tea extract | Active comparator | 200 mg EGCG as green tea extract and same volume water as for tea beverage. Receives: Dietary Supplement: Green tea extract |
| Epigallocatechin-3-gallate (EGCG) | Active comparator | 200 mg EGCG and same volume water as for tea beverage. Receives: Dietary Supplement: EGCG |
| Placebo (Water) | Placebo comparator | Same volume water as for all intervention arms. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the arteria brachialis
Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.
Measured: 2 hours after ingestion
Secondary outcomes (2)
Agonist-induced platelet aggregation in vitro
Blood is drawn two hours after consumption and the effects on in vitro agonist-induced platelet aggregation after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG are measured.
Measured: 2 hours after ingestion
Determination of plasma tea polyphenol levels
Blood is drawn two hours after consumption and plasma concentrations of tea polyphenols are measured after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG by HPLC.
Measured: 2 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Lorenz, PhD, Charite University, Berlin, Germany
- Investigators
- Mario Lorenz, PhD, Principal investigator, Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662232
- Sponsor's protocol ID
- Char-EGCG-FMD
- Status last verified
- Feb 2016
- First submitted
- 7 Aug 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01662232
- Acronym / sponsor ID
- Char-EGCG-FMD
- Conditions
- Cardiovascular Diseases
- Keywords
- Green tea, EGCG, Cardiovascular diseases, Endothelial function, Flow-mediated dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Aug 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.
Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.
Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.
In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Green tea beverage | Active comparator | Dietary Supplement: Green tea beverage200 mg EGCG as green tea beverage. |
| Green tea extract | Active comparator | Dietary Supplement: Green tea extract200 mg EGCG as green tea extract and same volume water as for tea beverage. |
| Epigallocatechin-3-gallate (EGCG) | Active comparator | Dietary Supplement: EGCG200 mg EGCG and same volume water as for tea beverage. |
| Placebo (Water) | Placebo comparator | Other: PlaceboSame volume water as for all intervention arms. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male healthy volunteers
- 20-50 years
- BMI < 27 kg/m2
- Cholesterol < 240 mg/dl
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Hypertension
- Conditions with impaired endothelial function
- Smoking
- Regular drug use
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 |
|---|---|---|
| Green tea beverage | Dietary supplement | Green tea beverage |
| Green tea extract | Dietary supplement | Green tea extract |
| EGCG | Dietary supplement | Epigallocatechin-3-gallate (EGCG) |
| Placebo | Other | Placebo (Water) |
Primary outcome
Flow-mediated dilation of the arteria brachialis
Time frame: 2 hours after ingestion
Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.
2 secondary outcomes
Agonist-induced platelet aggregation in vitro
Time frame: 2 hours after ingestion
Determination of plasma tea polyphenol levels
Time frame: 2 hours after ingestion
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 Feb 2016.
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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.
Mario Lorenz, PhD principal investigator
Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea beverage, Green tea extract and EGCG in people with Cardiovascular Diseases, run by Charite University, Berlin, Germany 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 4 inclusion and 7 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 Feb 2016. 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. 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?
Flow-mediated dilation of the arteria brachialis (time frame: 2 hours after ingestion). 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 Feb 2016; AzTrials last refreshed its copy on 29 Oct 2026.