Healthy MenCranberryNCT02517775
Effects of Cranberry Consumption in Vascular Function in Healthy Individuals
A study testing Cranberry 320, Cranberry 640 and Cranberry 960 in people with Healthy Men, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- Cranberry 320, Cranberry 640 and Cranberry 960
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Sep 2015
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects without clinical signs or symptoms of cardiovascular disease
Who cannot join
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
Show all 10Show fewer
- C-reactive protein > 05 mg/dL
- malignant disease
- cranberry allergy/intolerance
- hypotension (≤100 / 60 mm Hg)
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: Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals
Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.
- Conditions
- Healthy Men
- Being tested
- Cranberry 320, Cranberry 640, Cranberry 960, Cranberry 1280, Cranberry 1600
- Keywords
- polyphenols, vascular function, endothelial function, cranberry, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry 320Dietary supplement
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 640Dietary supplement
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 960Dietary supplement
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 1280Dietary supplement
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 1600Dietary supplement
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry deprived supplementDietary supplement
Cranberry deprived supplement Acute intake of 500 mL (1x daily)
| Study group | Role | What they receive |
|---|---|---|
| Cranberry 320 | Active comparator | Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry 320 |
| Cranberry 640 | Active comparator | Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry 640 |
| Cranberry 960 | Active comparator | Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry 960 |
| Cranberry 1280 | Active comparator | Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry 1280 |
| Cranberry 1600 | Active comparator | Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry 1600 |
| Cranberry deprived supplement | Placebo comparator | Placebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily) Receives: Dietary Supplement: Cranberry deprived supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake
Measured: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Secondary outcomes (4)
pulse wave velocity
measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake
Measured: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Central blood pressure
measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake
Measured: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Peripheral blood pressure
measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake
Measured: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Heart Rate
measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake
Measured: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
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 Healthy MenStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- The Cranberry Institute
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, Division of Cardiology, Pulmonology and Vascular MedicineChristian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517775
- Sponsor's protocol ID
- 14-012
- Acronym
- Cranberry
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mena 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 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02517775
- Acronym / sponsor ID
- Cranberry / 14-012
- Conditions
- Healthy Men
- Keywords
- polyphenols, vascular function, endothelial function, cranberry, healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- The Cranberry Institute
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Aug 2015 (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.
Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cranberry 320 | Active comparator | Dietary Supplement: Cranberry 320Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily) |
| Cranberry 640 | Active comparator | Dietary Supplement: Cranberry 640Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily) |
| Cranberry 960 | Active comparator | Dietary Supplement: Cranberry 960Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily) |
| Cranberry 1280 | Active comparator | Dietary Supplement: Cranberry 1280Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily) |
| Cranberry 1600 | Active comparator | Dietary Supplement: Cranberry 1600Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily) |
| Cranberry deprived supplement | Placebo comparator | Dietary Supplement: Cranberry deprived supplementPlacebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male subjects without clinical signs or symptoms of cardiovascular disease
Key exclusion criteria (10 listed)
- cardiovascular disease
- 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 320Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry 320 |
| Cranberry 640Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry 640 |
| Cranberry 960Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry 960 |
| Cranberry 1280Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry 1280 |
| Cranberry 1600Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry 1600 |
| Cranberry deprived supplementCranberry deprived supplement Acute intake of 500 mL (1x daily) | Dietary supplement | Cranberry deprived supplement |
Primary outcome
Endothelial function
Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake
4 secondary outcomes
pulse wave velocity
Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Central blood pressure
Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Peripheral blood pressure
Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
Heart Rate
Time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption
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 Nov 2015.
- 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.
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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-Mateos, PhD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
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 320, Cranberry 640 and Cranberry 960 in people with Healthy Men, 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 1 inclusion and 10 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 Nov 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. 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?
Endothelial function (time frame: Baseline, on week 1, 2, 3, 4 and 5 postconsumption). 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 NCT02517775, 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 3 Nov 2015.