Healthy YoungNCT02764749
Cranberry (Poly)Phenol Consumption on Vascular Function
A study testing cranberry (poly)phenol containing supplement in people with Healthy Young, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young
- What is being tested?
- cranberry (poly)phenol containing supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Oct 2016
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects (no clinical signs or symptoms of CVD)
- Young >18 years, <35 years
Who cannot join
- CVD
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- CRP > 1 mg/dl
- malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, 40225
About this study
Official title: Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals
Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.
- Conditions
- Healthy Young
- Being tested
- cranberry (poly)phenol containing supplement, Placebo comparator: cranberry (poly)phenol deprived supplement
- Keywords
- vascular function, endothelial function, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranberry (poly)phenol containing supplementDietary supplement
Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.
Placebo comparator: cranberry (poly)phenol deprived supplementDietary supplement
Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| freeze dried powder whole cranberry dissolved in water | Experimental | Dietary Supplement: freeze dried cranberry powder Receives: Dietary Supplement: cranberry (poly)phenol containing supplement |
| freeze dried cranberry deprived powder dissolved in water | Placebo comparator | Placebo comparator: freeze dried cranberry deprived powder Receives: Dietary Supplement: Placebo comparator: cranberry (poly)phenol deprived supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form Baseline Endothelial function at 1 month
Measured by Flow mediated dilation (FMD)
Measured: 2 hours and 1 month
Secondary outcomes (5)
Pulse wave velocity
Measured by SphygmoCor 0 and 2 hours postconsumption
Measured: Baseline and 1 month
Blood pressure
automatical measurements 0 and 2 hours postconsumption
Measured: Baseline and 1month
high density lipoproteins (HDL)
measured on baseline and after 1 month
Measured: Baseline and 1 month
low density lipoproteins (LDL)
measured on baseline and after 1 month
Measured: Baseline and 1 month
triglyceride
measured on baseline and after 1 month
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy YoungStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Ana Rodriguez-Mateo, PhD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764749
- Sponsor's protocol ID
- Cranberry
- Other IDs
- 15-042
- Status last verified
- Nov 2016
- First submitted
- 4 May 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heiss C, Istas G, Feliciano RP, Weber T, Wang B, Favari C, Mena P, Del Rio D, Rodriguez-Mateos A. Daily consumption of cranberry improves endothelial function in healthy adults: a double blind randomized controlled trial. Food Funct. 2022 Apr 4;13(7):3812-3824. doi: 10.1039/d2fo00080f.
PubMed 35322843Mena P, Favari C, Acharjee A, Chernbumroong S, Bresciani L, Curti C, Brighenti F, Heiss C, Rodriguez-Mateos A, Del Rio D. Metabotypes of flavan-3-ol colonic metabolites after cranberry intake: elucidation and statistical approaches. Eur J Nutr. 2022 Apr;61(3):1299-1317. doi: 10.1007/s00394-021-02692-z. Epub 2021 Nov 9.
PubMed 34750642
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02764749
- Acronym / sponsor ID
- Cranberry
- Conditions
- Healthy Young
- Keywords
- vascular function, endothelial function, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 May 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.
Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freeze dried powder whole cranberry dissolved in water | Experimental | Dietary Supplement: cranberry (poly)phenol containing supplementDietary Supplement: freeze dried cranberry powder |
| freeze dried cranberry deprived powder dissolved in water | Placebo comparator | Dietary Supplement: Placebo comparator: cranberry (poly)phenol deprived supplementPlacebo comparator: freeze dried cranberry deprived powder |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male subjects (no clinical signs or symptoms of CVD)
- Young >18 years, <35 years
Key exclusion criteria (8 listed)
- CVD
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
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 |
|---|---|---|
| cranberry (poly)phenol containing supplementSustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink. | Dietary supplement | freeze dried powder whole cranberry dissolved in water |
| Placebo comparator: cranberry (poly)phenol deprived supplementSustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water | Dietary supplement | freeze dried cranberry deprived powder dissolved in water |
Primary outcome
Change form Baseline Endothelial function at 1 month
Time frame: 2 hours and 1 month
Measured by Flow mediated dilation (FMD)
5 secondary outcomes
Pulse wave velocity
Time frame: Baseline and 1 month
Blood pressure
Time frame: Baseline and 1month
high density lipoproteins (HDL)
Time frame: Baseline and 1 month
low density lipoproteins (LDL)
Time frame: Baseline and 1 month
triglyceride
Time frame: Baseline and 1 month
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 28 Nov 2016.
- Derived from this study: PubMed 35322843Heiss C, Istas G, Feliciano RP, Weber T, Wang B, Favari C, Mena P, Del Rio D, Rodriguez-Mateos A. Daily consumption of cranberry improves endothelial function in healthy adults: a double blind randomized controlled trial. Food Funct. 2022 Apr 4;13(7):3812-3824. doi: 10.1039/d2fo00080f.
- Derived from this study: PubMed 34750642Mena P, Favari C, Acharjee A, Chernbumroong S, Bresciani L, Curti C, Brighenti F, Heiss C, Rodriguez-Mateos A, Del Rio D. Metabotypes of flavan-3-ol colonic metabolites after cranberry intake: elucidation and statistical approaches. Eur J Nutr. 2022 Apr;61(3):1299-1317. doi: 10.1007/s00394-021-02692-z. Epub 2021 Nov 9.
- Individual participant dataSharing planned: No
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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.
Ana Rodriguez-Mateo, PhD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cranberry (poly)phenol containing supplement in people with Healthy Young, run by Heinrich-Heine University, Duesseldorf 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 2 inclusion and 8 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 28 Nov 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?
Change form Baseline Endothelial function at 1 month (time frame: 2 hours and 1 month). 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 NCT02764749, which also lists 2 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 28 Nov 2016.