An interventional study of Placebo and Aronia extract in Prehypertension and Healthy, sponsored by King's College London. Completed at 2 sites in United Kingdom. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 102 is above the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Dietary Supplement: Placebo
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Dietary Supplement: Aronia extract
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Powdered extract obtained from aronia berries (Aronia melanocarpa).
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.
Time frame: Baseline and 12 weeks
Office blood pressure
Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Blood cortisol
Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption
Time frame: 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.
Time frame: 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
Time frame: Baseline and 12 weeks
Plasma aronia berry (poly)phenol metabolites
Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption at day 1 (baseline) and after 12 weeks.
Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Microbiome analysis
Stool sample collection (Omnigene gut collection kit)
Time frame: Baseline and 12 weeks
Plan to share: No
Ran from Feb 2018 to primary completion in Sep 2019, 18 months.
Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's 18 months is close to that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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