End Stage Renal DiseasePhase 2ESRDNCT00835887
Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease
A Phase 2 study testing low and high dose flavanoids in people with End Stage Renal Disease, run by RWTH Aachen University at 1 site in Germany.
Trial summary
In this study, the acute and long-term effects of flavanols on vascular function in patients with ESRD will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- low and high dose flavanoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with end stage renal disease
Who cannot join
- person under 18 years of age
- participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease, a Phase 2 Study
In this study, the acute and long-term effects of flavanols on vascular function in patients with ESRD will be investigated.
Read the detailed description
In order to assess potential acute beneficial effects of flavanols in patients with ESRD, 10 patients undergoing dialysis will be recruited. Subjects will receive a cocoa drink with 16 mg, 250 mg, and 500 mg (in 100 mL water each) flavan-3-ols (40% epicatechine/catechine und 60% procyanidine), respectively, on three consecutively days. The functional/hemodynamic parameters (flowmediated dilation (FMD), venous-occlusion-plethysmography (VOP), blood pressure, heart rate), the biochemical marker of the circulating NO pool (nitrite, nitrate, RNOs), and the plasma levels of flavanols (epicatechine and catechine) will be determined before and after ingestion of the respective cocoadrink.
It is expected that flavanols dose-dependently improve vascular function and that this is associated with an increase in the circulating NO pool.
In order to assess long-term effects of flavanols on vascular function in patients with ESRD.
To characterize potential vascular long-term effects of flavanols in patients with ESRD, a placebo-controlled double-blinded randomized control study will be performed in 40 patients randomized in two groups. Patients will daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of three months.
The flavanol-dosis that is necessary to affect vascular function will be assessed as described above. At the beginning of the study, after the first intake of the cocoa (in order to identify nonresponders) and monthly for a period of three months the vascular function will be assessed applying innovative imaging techniques to the brachial artery to assess endothelium-dependent regulation of physicomechanical properties and vascular tone and thus blood flow at the level of the macrocirculation. In parallel new techniques will be applied to assess perfusion at the level of the microcirculation. In particular, measurement of flow-mediated dilation, intima-media-thickness,compliance and stiffness indices will be performed in the macrocirculation of the brachial artery.
Considering the microcirculation, new diagnostic approaches such as Laser-Doppler Flow and peripheral arterial tonometry next to diagnostic approaches such as the venous occlusive plethysmography will be performed. Moreover, the circulating NO pool, markers of inflammation and of oxidative stress, the uremic toxin pcresol and the plasma levels of flavanols will be determined. The exams after month 1, 2, and 3 will be performed in the morning before intake of the cocoa drink. In order to examine potential sustained effects, an additional examination day will take place after 4 month (one month after stopping the flavanol-intake). It is expected that the flavanol-rich cocoa will improve vascular function, which is associated with an increase in the circulating NO-pool and a decrease in inflammatory markers and the marker for oxidative stress.
- Conditions
- End Stage Renal Disease
- Being tested
- low and high dose flavanoids
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low and high dose flavanoidsDietary supplement
treatment with flavanoid-rich or flavanoid-low cacao twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with low dose flavanoids Receives: Dietary Supplement: low and high dose flavanoids |
| 2 | Experimental | Treatment with high dose flavanoids Receives: Dietary Supplement: low and high dose flavanoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Measured: before treatment, directly after treatment and 3, resp. 4 months afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
Why it stopped: no patients recruited, responsible physician left clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835887
- Sponsor's protocol ID
- ESRD-Study
- Acronym
- ESRD
- Status last verified
- Sep 2015
- First submitted
- 3 Feb 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease, a Phase 2 Study
- ClinicalTrials.gov ID
- NCT00835887
- Acronym / sponsor ID
- ESRD / ESRD-Study
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients recruited, responsible physician left clinic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- First posted
- 4 Feb 2009 (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.
In this study, the acute and long-term effects of flavanols on vascular function in patients with ESRD will be investigated.
Detailed description
In order to assess potential acute beneficial effects of flavanols in patients with ESRD, 10 patients undergoing dialysis will be recruited. Subjects will receive a cocoa drink with 16 mg, 250 mg, and 500 mg (in 100 mL water each) flavan-3-ols (40% epicatechine/catechine und 60% procyanidine), respectively, on three consecutively days. The functional/hemodynamic parameters (flowmediated dilation (FMD), venous-occlusion-plethysmography (VOP), blood pressure, heart rate), the biochemical marker of the circulating NO pool (nitrite, nitrate, RNOs), and the plasma levels of flavanols (epicatechine and catechine) will be determined before and after ingestion of the respective cocoadrink.
It is expected that flavanols dose-dependently improve vascular function and that this is associated with an increase in the circulating NO pool.
In order to assess long-term effects of flavanols on vascular function in patients with ESRD.
To characterize potential vascular long-term effects of flavanols in patients with ESRD, a placebo-controlled double-blinded randomized control study will be performed in 40 patients randomized in two groups. Patients will daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of three months.
The flavanol-dosis that is necessary to affect vascular function will be assessed as described above. At the beginning of the study, after the first intake of the cocoa (in order to identify nonresponders) and monthly for a period of three months the vascular function will be assessed applying innovative imaging techniques to the brachial artery to assess endothelium-dependent regulation of physicomechanical properties and vascular tone and thus blood flow at the level of the macrocirculation. In parallel new techniques will be applied to assess perfusion at the level of the microcirculation. In particular, measurement of flow-mediated dilation, intima-media-thickness,compliance and stiffness indices will be performed in the macrocirculation of the brachial artery.
Considering the microcirculation, new diagnostic approaches such as Laser-Doppler Flow and peripheral arterial tonometry next to diagnostic approaches such as the venous occlusive plethysmography will be performed. Moreover, the circulating NO pool, markers of inflammation and of oxidative stress, the uremic toxin pcresol and the plasma levels of flavanols will be determined. The exams after month 1, 2, and 3 will be performed in the morning before intake of the cocoa drink. In order to examine potential sustained effects, an additional examination day will take place after 4 month (one month after stopping the flavanol-intake). It is expected that the flavanol-rich cocoa will improve vascular function, which is associated with an increase in the circulating NO-pool and a decrease in inflammatory markers and the marker for oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: low and high dose flavanoidsTreatment with low dose flavanoids |
| 2 | Experimental | Dietary Supplement: low and high dose flavanoidsTreatment with high dose flavanoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with end stage renal disease
Key exclusion criteria (2 listed)
- person under 18 years of age
- participation in another study
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 |
|---|---|---|
| low and high dose flavanoidstreatment with flavanoid-rich or flavanoid-low cacao twice daily | Dietary supplement | 1, 2 |
Primary outcome
Vascular function
Time frame: before treatment, directly after treatment and 3, resp. 4 months afterwards
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low and high dose flavanoids in people with End Stage Renal Disease, run by RWTH Aachen University 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 1 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: withdrawn, as of the sponsor's last update on 23 Sep 2015. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Vascular function (time frame: before treatment, directly after treatment and 3, resp. 4 months afterwards). 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 23 Sep 2015.