Clinical trial NCT03434574: Aronia Berry Consumption on Blood Pressure
Official title: Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Healthy
Keywords: (Poly)phenols
Aronia berry
Blood pressure
Vascular function
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Naturex-Dbs
First posted: 2018-02-15
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Changes from baseline ambulatory blood pressure after 12-week consumption
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Office blood pressure
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Heart rate
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Flow-mediated dilation
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Blood flow velocity
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Pulse wave velocity (PWV)
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Augmentation Index (AIx)
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Blood lipids
timeFrame: Baseline and 12 weeks
measure: Blood cortisol
timeFrame: Baseline and 12 weeks
measure: Number of volunteers with treatment-related adverse events
timeFrame: Baseline and 12 weeks
measure: 24-hour heart rate
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Plasma aronia berry (poly)phenol metabolites
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Microbiome analysis
timeFrame: Baseline and 12 weeks
Locations:
city: London
country: United Kingdom
facility: Department of Life Sciences and Medecine
state: Central London
city: London
country: United Kingdom
facility: King's College London
state: England
Study officials:
References:
citation: 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.