HealthyNCT02520830
Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism
A study testing Blueberry Group in people with Healthy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies. Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blueberry Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Mar 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male subjects without clinical signs or symptoms of cardiovascular disease
- 18-70 years
Who cannot join
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- C- reactive protein > 1mg/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 Blueberry Polyphenols on Vascular Function in Healthy Individuals
Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies.
Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Wild blueberries have gained attention due to their high content of phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular function and health 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 wild blueberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk.
- Conditions
- Healthy
- Being tested
- Blueberry Group, Placebo Group
- Keywords
- blueberry polyphenols, Polyphenol metabolites, endothelial function, Molecular mechanisms of action, Vascular function, Healthy men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry GroupDietary supplement
22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water
Placebo GroupDietary supplement
Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Group | Active comparator | Dietary Supplement: 22 gram freeze-dried blueberry powder per day Receives: Dietary Supplement: Blueberry Group |
| Placebo Group | Placebo comparator | blueberry polyphenol deprived powder 22 gram per day Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption
Measured: baseline and 1 month
Secondary outcomes (3)
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 1 month
Blood lipids
biochemical analysis, 0 and 2 hours postconsumption
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 posted13 Aug 2015 (estimated)
- Study startMar 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 HealthyStudies 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
- 45 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-Mateos, PhD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital DuesseldorfChristian Heiss, MD, Study chair, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520830
- Sponsor's protocol ID
- Blueberries
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Mateos A, Istas G, Boschek L, Feliciano RP, Mills CE, Boby C, Gomez-Alonso S, Milenkovic D, Heiss C. Circulating Anthocyanin Metabolites Mediate Vascular Benefits of Blueberries: Insights From Randomized Controlled Trials, Metabolomics, and Nutrigenomics. J Gerontol A Biol Sci Med Sci. 2019 Jun 18;74(7):967-976. doi: 10.1093/gerona/glz047.
PubMed 30772905
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
- Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02520830
- Acronym / sponsor ID
- Blueberries
- Conditions
- Healthy
- Keywords
- blueberry polyphenols, Polyphenol metabolites, endothelial function, Molecular mechanisms of action, Vascular function, Healthy men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 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.
Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies.
Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Wild blueberries have gained attention due to their high content of phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular function and health 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 wild blueberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Group | Active comparator | Dietary Supplement: Blueberry GroupDietary Supplement: 22 gram freeze-dried blueberry powder per day |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo Groupblueberry polyphenol deprived powder 22 gram per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male subjects without clinical signs or symptoms of cardiovascular disease
- 18-70 years
Key exclusion criteria (8 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 |
|---|---|---|
| Blueberry Group22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water | Dietary supplement | Blueberry Group |
| Placebo GroupSustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water | Dietary supplement | Placebo Group |
Primary outcome
Endothelial function
Time frame: baseline and 1 month
Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption
3 secondary outcomes
Pulse wave velocity
Time frame: baseline and 1 month
Blood pressure
Time frame: baseline and 1 month
Blood lipids
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 3 Nov 2015.
- Derived from this study: PubMed 30772905Rodriguez-Mateos A, Istas G, Boschek L, Feliciano RP, Mills CE, Boby C, Gomez-Alonso S, Milenkovic D, Heiss C. Circulating Anthocyanin Metabolites Mediate Vascular Benefits of Blueberries: Insights From Randomized Controlled Trials, Metabolomics, and Nutrigenomics. J Gerontol A Biol Sci Med Sci. 2019 Jun 18;74(7):967-976. doi: 10.1093/gerona/glz047.
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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, University Hospital Duesseldorf
Christian Heiss, MD study chair
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 Blueberry Group in people with Healthy, 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 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 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 NCT02520830, 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.