HealthyNCT02734901
Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals
A study testing 400 g frozen raspberries and 200 g frozen raspberries in people with Healthy, 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. 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
- What is being tested?
- 400 g frozen raspberries and 200 g frozen raspberries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Sep 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects (no 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
- raspberry 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
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. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and 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 have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.
- Conditions
- Healthy
- Being tested
- 400 g frozen raspberries, 200 g frozen raspberries, Placebo
- Keywords
- polyphenols, vascular function, endothelial function, raspberry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 g frozen raspberriesDietary supplement
1x daily intake of 600 mL red raspberry beverage
200 g frozen raspberriesDietary supplement
1x daily intake of 600 mL red raspberry beverage
PlaceboDietary supplement
1x daily intake of 600 mL raspberry deprived supplement
| Study group | Role | What they receive |
|---|---|---|
| 400 g frozen raspberries | Active comparator | Red raspberry beverage Acute intake of 600 mL (1x daily) Receives: Dietary Supplement: 400 g frozen raspberries |
| 200 g frozen raspberries | Active comparator | Red raspberry beverage Acute intake of 600 mL (1x daily) Receives: Dietary Supplement: 200 g frozen raspberries |
| Placebo control | Placebo comparator | Raspberry deprived supplement Acute intake of 600 mL (1x daily) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 2 hour and 24 hour in Endothelial function
measured by flow mediated dilation (FMD) on baseline at 2 and 24 hour postconsumption
Measured: Baseline, 2 hour and 24 hour
Secondary outcomes (4)
Change from baseline to 2 hour and 24 hour in Pulse wave velocity
measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption
Measured: Baseline, 2 hour and 24 hour
Change from baseline to 2 hour and 24 hour in Central blood pressure
measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption
Measured: Baseline, 2 hour and 24 hour
Peripheral blood pressure
measured by automatic sphygmomanometer on baseline at 2 and 24 hours postconsumption
Measured: Baseline, 2 h and 24 h
Change from baseline to 2 hour and 24 hour in Heart rate
measured by SphygmoCor on baseline at 2 and 24 hours postconsumption
Measured: Baseline, 2 hour and 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital DuesseldorfChristian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734901
- Sponsor's protocol ID
- Rapsberry
- Other IDs
- 15-038
- Status last verified
- Oct 2016
- First submitted
- 9 Mar 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Istas G, Feliciano RP, Weber T, Garcia-Villalba R, Tomas-Barberan F, Heiss C, Rodriguez-Mateos A. Plasma urolithin metabolites correlate with improvements in endothelial function after red raspberry consumption: A double-blind randomized controlled trial. Arch Biochem Biophys. 2018 Aug 1;651:43-51. doi: 10.1016/j.abb.2018.05.016. Epub 2018 May 24.
PubMed 29802820
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02734901
- Acronym / sponsor ID
- Rapsberry
- Conditions
- Healthy
- Keywords
- polyphenols, vascular function, endothelial function, raspberry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Apr 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.
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. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and 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 have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 g frozen raspberries | Active comparator | Dietary Supplement: 400 g frozen raspberriesRed raspberry beverage Acute intake of 600 mL (1x daily) |
| 200 g frozen raspberries | Active comparator | Dietary Supplement: 200 g frozen raspberriesRed raspberry beverage Acute intake of 600 mL (1x daily) |
| Placebo control | Placebo comparator | Dietary Supplement: PlaceboRaspberry deprived supplement Acute intake of 600 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 (no 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 |
|---|---|---|
| 400 g frozen raspberries1x daily intake of 600 mL red raspberry beverage | Dietary supplement | 400 g frozen raspberries |
| 200 g frozen raspberries1x daily intake of 600 mL red raspberry beverage | Dietary supplement | 200 g frozen raspberries |
| Placebo1x daily intake of 600 mL raspberry deprived supplement | Dietary supplement | Placebo control |
Primary outcome
Change from baseline to 2 hour and 24 hour in Endothelial function
Time frame: Baseline, 2 hour and 24 hour
measured by flow mediated dilation (FMD) on baseline at 2 and 24 hour postconsumption
4 secondary outcomes
Change from baseline to 2 hour and 24 hour in Pulse wave velocity
Time frame: Baseline, 2 hour and 24 hour
Change from baseline to 2 hour and 24 hour in Central blood pressure
Time frame: Baseline, 2 hour and 24 hour
Peripheral blood pressure
Time frame: Baseline, 2 h and 24 h
Change from baseline to 2 hour and 24 hour in Heart rate
Time frame: Baseline, 2 hour and 24 hour
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 20 Oct 2016.
- Derived from this study: PubMed 29802820Istas G, Feliciano RP, Weber T, Garcia-Villalba R, Tomas-Barberan F, Heiss C, Rodriguez-Mateos A. Plasma urolithin metabolites correlate with improvements in endothelial function after red raspberry consumption: A double-blind randomized controlled trial. Arch Biochem Biophys. 2018 Aug 1;651:43-51. doi: 10.1016/j.abb.2018.05.016. Epub 2018 May 24.
- 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-Mateos, PhD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Christian Heiss, MD 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 400 g frozen raspberries and 200 g frozen raspberries 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 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 20 Oct 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 from baseline to 2 hour and 24 hour in Endothelial function (time frame: Baseline, 2 hour and 24 hour). 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 NCT02734901, 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 20 Oct 2016.