PrehypertensionABPNCT03434574
Aronia Berry Consumption on Blood Pressure
A study testing Aronia extract in people with Prehypertension and Healthy, run by King's College London at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Healthy
- What is being tested?
- Aronia extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Feb 2018to 12 Sep 2019
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 40-70 years old
- Blood pressure comprised between: SBP 120/139 mmHg or DBP 80/89 mmHg
- 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 and willing 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
- Grade 1 hypertensive or above, 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
- Chronic and acute disease
Show all 21Show fewer
- Terminal renal failure and other kidney abnormalities
- Malignancies
- Abnormal heart rhythm
- Allergies to berries or other significant food allergy.
- Subjects who require treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs)
- Subjects who took food supplements, dietary supplement or herbal remedies within 1 month of study start
- 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 1 month before the study start
- Subjects who smoke an irregular amount of cigarettes per day
- Subjects who require chronic antimicrobial or antiviral treatment
- Subjects with unstable psychological condition
- Subjects with history of cancer, myocardial infarction, cerebrovascular incident
- Unable to swallow the capsule
- Pregnant, lactating or planning to become pregnant, as well as premenopausal women who do not have an adequate method of contraception
- 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
2 sites in 1 country.
United Kingdom2 sites
Department of Life Sciences and Medecine
London, Central London, SE1 9NH
King's College London
London, England, SE1 9NH
About this study
Official title: Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
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 polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.
- Conditions
- Prehypertension, Healthy
- Being tested
- Placebo, Aronia extract
- Keywords
- (Poly)phenols, Aronia berry, Blood pressure, Vascular function
- Medical subject headings
- Prehypertension
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 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 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.
Changes from baseline ambulatory blood pressure after 12-week consumption
Determine the effect of the Aronia extract vs Placebo on ambulatory 24-hour systolic and diastolic blood pressure at 12 weeks post consumption, compared to the baseline.
Measured: Baseline and 12 weeks
Secondary outcomes (10)
Office blood pressure
Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Heart rate
Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Flow-mediated dilation
Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood flow velocity
Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Pulse wave velocity (PWV)
Determine the effect of the Aronia extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Augmentation Index (AIx)
Determine the effect of the Aronia extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption
Measured: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood lipids
Determine the effect of the Aronia extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption
Measured: Baseline and 12 weeks
Blood cortisol
Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption
Measured: Baseline and 12 weeks
Number of volunteers with treatment-related adverse events
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Measured: Baseline and 12 weeks
24-hour heart rate
Determine the effect of the Aronia extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption
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 posted15 Feb 2018
- Study start20 Feb 2018
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
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 PrehypertensionStudies 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
- 102 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
- NCT03434574
- Sponsor's protocol ID
- Aronia BP
- Acronym
- ABP
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Sayec M, Xu Y, Laiola M, Gallego FA, Katsikioti D, Durbidge C, Kivisild U, Armes S, Lecomte M, Fanca-Berthon P, Fromentin E, Plaza Onate F, Cruickshank JK, Rodriguez-Mateos A. The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial. Clin Nutr. 2022 Nov;41(11):2549-2561. doi: 10.1016/j.clnu.2022.08.024. Epub 2022 Sep 6.
PubMed 36228567
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
- ClinicalTrials.gov ID
- NCT03434574
- Acronym / sponsor ID
- ABP / Aronia BP
- Conditions
- Prehypertension, Healthy
- Keywords
- (Poly)phenols, Aronia berry, Blood pressure, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Naturex-Dbs
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 15 Feb 2018 (actual)
- 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.
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 polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| 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 extract | Active comparator | Dietary Supplement: Aronia extractFormulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men and women aged 40-70 years old
- Blood pressure comprised between: SBP 120/139 mmHg or DBP 80/89 mmHg
- 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 and willing to give signed written informed consent
Key exclusion criteria (21 listed)
- Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Grade 1 hypertensive or above, 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 extractPowdered extract obtained from aronia berries (Aronia melanocarpa). | Dietary supplement | Aronia extract |
Primary outcome
Changes from baseline ambulatory blood pressure after 12-week consumption
Time frame: Baseline and 12 weeks
Determine the effect of the Aronia extract vs Placebo on ambulatory 24-hour systolic and diastolic blood pressure at 12 weeks post consumption, compared to the baseline.
10 secondary outcomes
Office blood pressure
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Heart rate
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Flow-mediated dilation
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood flow velocity
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Pulse wave velocity (PWV)
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Augmentation Index (AIx)
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood lipids
Time frame: Baseline and 12 weeks
Blood cortisol
Time frame: Baseline and 12 weeks
Number of volunteers with treatment-related adverse events
Time frame: Baseline and 12 weeks
24-hour heart rate
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 23 Sep 2019.
- Derived from this study: PubMed 36228567Le Sayec M, Xu Y, Laiola M, Gallego FA, Katsikioti D, Durbidge C, Kivisild U, Armes S, Lecomte M, Fanca-Berthon P, Fromentin E, Plaza Onate F, Cruickshank JK, Rodriguez-Mateos A. The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial. Clin Nutr. 2022 Nov;41(11):2549-2561. doi: 10.1016/j.clnu.2022.08.024. Epub 2022 Sep 6.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aronia extract in people with Prehypertension and Healthy, run by King's College London at 2 sites 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 6 inclusion and 21 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes from baseline ambulatory blood pressure after 12-week consumption (time frame: Baseline and 12 weeks). 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 NCT03434574, 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 23 Sep 2019.