End Stage Renal DiseasePhase 1/2NCT01412320
Cocoa Flavanols in Renal Disease
A Phase 1/2 study testing Cocoa in people with End Stage Renal Disease and Endothelial Dysfunction, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD). Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Endothelial Dysfunction
- What is being tested?
- Cocoa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 1/2
- 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
- end stage renal disease
- >18 years
- chronic intermittent hemodialysis
Who cannot join
- acute Infection
- acute renal failure
- heart failure (NYHA IV)
- pregnancy
- anuria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).
Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.
- Conditions
- End Stage Renal Disease, Endothelial Dysfunction
- Being tested
- Cocoa
- 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.
CocoaOther
dissolved in water twice daily
CocoaOther
dissolved in water twice daily
| Study group | Role | What they receive |
|---|---|---|
| Flavanol rich cocoa | Experimental | Not described Receives: Other: Cocoa |
| Flavanol poor | Experimental | Not described Receives: Other: Cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412320
- Sponsor's protocol ID
- ESRD_2010
- Status last verified
- Nov 2013
- First submitted
- 5 Aug 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008 Jun 3;51(22):2141-9. doi: 10.1016/j.jacc.2008.01.059.
PubMed 18510961Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745Luedike P, Rammos C, Pohl J, Heisler M, Totzeck M, Kleophas W, Hetzel GR, Kelm M, Hendgen-Cotta U, Rassaf T. Filtration of Macrophage Migration Inhibitory Factor (MIF) in Patients with End Stage Renal Disease Undergoing Hemodialysis. PLoS One. 2015 Oct 20;10(10):e0140215. doi: 10.1371/journal.pone.0140215. eCollection 2015.
PubMed 26485680
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT01412320
- Acronym / sponsor ID
- ESRD_2010
- Conditions
- End Stage Renal Disease, Endothelial Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Aug 2011 (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.
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).
Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavanol rich cocoa | Experimental | Other: Cocoa |
| Flavanol poor | Experimental | Other: Cocoa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- end stage renal disease
- >18 years
- chronic intermittent hemodialysis
Key exclusion criteria (5 listed)
- acute Infection
- acute renal failure
- heart failure (NYHA IV)
- pregnancy
- anuria
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 |
|---|---|---|
| Cocoadissolved in water twice daily | Other | Flavanol rich cocoa |
| Cocoadissolved in water twice daily | Other | Flavanol poor |
Primary outcome
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
Time frame: 30 days
To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD
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 Nov 2013.
- Background: PubMed 18510961Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008 Jun 3;51(22):2141-9. doi: 10.1016/j.jacc.2008.01.059.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Derived from this study: PubMed 26485680Luedike P, Rammos C, Pohl J, Heisler M, Totzeck M, Kleophas W, Hetzel GR, Kelm M, Hendgen-Cotta U, Rassaf T. Filtration of Macrophage Migration Inhibitory Factor (MIF) in Patients with End Stage Renal Disease Undergoing Hemodialysis. PLoS One. 2015 Oct 20;10(10):e0140215. doi: 10.1371/journal.pone.0140215. eCollection 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 1/2 study testing Cocoa in people with End Stage Renal Disease and Endothelial Dysfunction, run by Klinik für Kardiologie, Pneumologie und Angiologie 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 5 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 Nov 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion. (time frame: 30 days). 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 NCT01412320, which also lists 3 linked publications.
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 Nov 2013.