Aronia Berry Consumption on Blood Pressure

Healthy Clinical Trial

— ABP  

Official title:

Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434574
• Other study ID #: Aronia BP
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: September 12, 2019

Study information

• Verified date: September 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Prehypertension

Intervention

Dietary Supplement:
• Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
• Aronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa).

Locations

Country	Name	City	State
United Kingdom	Department of Life Sciences and Medecine	London	Central London
United Kingdom	King's College London	London	England

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Naturex-Dbs

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Other	Microbiome analysis	Stool sample collection (Omnigene gut collection kit)	Baseline and 12 weeks
Primary	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.	Baseline and 12 weeks
Secondary	Office blood pressure	Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	Heart rate	Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	Flow-mediated dilation	Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	Blood flow velocity	Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	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	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	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	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	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	Baseline and 12 weeks
Secondary	Blood cortisol	Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption	Baseline and 12 weeks
Secondary	Number of volunteers with treatment-related adverse events	The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.	Baseline and 12 weeks
Secondary	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	Baseline and 12 weeks