Healthy Young MenNCT03041961
Aronia Berry Consumption on Vascular Function
A study testing Aronia full spectrum and Aronia extract in people with Healthy Young Men, run by King's College London at 1 site in United Kingdom.
Trial summary
There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Men
- What is being tested?
- Aronia full spectrum and Aronia extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2017to 20 Jul 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged 18-45 years old
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
- Signed informed consent form
Who cannot join
- Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
- Obese participants, defined as BMI superior or equal to 30
- Diabetes mellitus and metabolic syndrome
- Acute inflammation
- Terminal renal failure
Show all 15Show fewer
- Malignancies
- Abnormal heart rhythm (lower or higher than 60-100 bpm)
- Allergies to berries or other significant food allergy.
- Subjects under medication or on vitamin/dietary supplements.
- Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
- Subjects who reported participant in another study within one month before the study start
- Subjects who smoke an irregular amount of cigarettes per day
- Unable to swallow the capsule
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Life Sciences and Medecine
London, Central London, SE1 9NH
About this study
Official title: Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.
There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.
Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.
Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts of differing polyphenol dose on vascular endothelial function.
- Conditions
- Healthy Young Men
- Being tested
- Placebo, Aronia full spectrum, Aronia extract
- Keywords
- Vascular function, Endothelial function, (Poly)phenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Aronia full spectrumDietary supplement
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
Aronia extractDietary supplement
Powdered extract obtained from aronia berries (Aronia melanocarpa)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg) Receives: Dietary Supplement: Placebo |
| Aronia full spectrum | Active comparator | Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg) Receives: Dietary Supplement: Aronia full spectrum |
| Aronia extract | Active comparator | Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg) Receives: Dietary Supplement: Aronia extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
Change form Baseline Endothelial function at 12 weeks
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary outcomes (7)
Pulse wave velocity
Measured by SphygmoCor 0 and 2 hours postconsumption
Measured: Baseline and 12 weeks
Blood pressure
Automatical measurements 0 and 2 hours postconsumption
Measured: Baseline and 12 weeks
Blood measurements- Blood lipids
Cholesterol, HDL, LDL, triglycerides
Measured: Baseline and 12 weeks
Blood measurements
Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils
Measured: Baseline and 12 weeks
Blood measurements-Electrolytes
Urea, Creatinine, uric acid
Measured: Baseline and 12 weeks
Blood measurements
Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)
Measured: Baseline and 12 weeks
Blood measurements -Glucose
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start14 Feb 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
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 Young MenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex-Dbs
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041961
- Sponsor's protocol ID
- Aronia FMD
- Status last verified
- Jul 2019
- First submitted
- 2 Feb 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075.
PubMed 31152545
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03041961
- Acronym / sponsor ID
- Aronia FMD
- Conditions
- Healthy Young Men
- Keywords
- Vascular function, Endothelial function, (Poly)phenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Naturex-Dbs
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 3 Feb 2017 (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.
There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.
Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.
Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts of differing polyphenol dose on vascular endothelial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFormulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg) |
| Aronia full spectrum | Active comparator | Dietary Supplement: Aronia full spectrumFormulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg) |
| Aronia extract | Active comparator | Dietary Supplement: Aronia extractFormulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men aged 18-45 years old
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
- Signed informed consent form
Key exclusion criteria (15 listed)
- Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
- Obese participants, defined as BMI superior or equal to 30
- Diabetes mellitus and metabolic syndrome
- Acute inflammation
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 |
|---|---|---|
| PlaceboIdentical formulation as the treatment consisting of colored maltodextrin using artificial colors. | Dietary supplement | Placebo |
| Aronia full spectrumPowdered whole fruit obtained from aronia berries (Aronia melanocarpa) | Dietary supplement | Aronia full spectrum |
| Aronia extractPowdered extract obtained from aronia berries (Aronia melanocarpa) | Dietary supplement | Aronia extract |
Primary outcome
Flow-mediated dilation
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Change form Baseline Endothelial function at 12 weeks
7 secondary outcomes
Pulse wave velocity
Time frame: Baseline and 12 weeks
Blood pressure
Time frame: Baseline and 12 weeks
Blood measurements- Blood lipids
Time frame: Baseline and 12 weeks
Blood measurements
Time frame: Baseline and 12 weeks
Blood measurements-Electrolytes
Time frame: Baseline and 12 weeks
Blood measurements
Time frame: Baseline and 12 weeks
Blood measurements -Glucose
Time frame: Baseline and 12 weeks
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 5 Jul 2019.
- Derived from this study: PubMed 31152545Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075.
- 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.
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 study testing Aronia full spectrum and Aronia extract in people with Healthy Young Men, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 15 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 5 Jul 2019. 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 United Kingdom. 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?
Flow-mediated dilation (time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours). 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 NCT03041961, 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 5 Jul 2019.