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Aronia Berry Consumption on Blood Pressure (ABP)

Primary Purpose

Prehypertension, Healthy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Aronia extract
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prehypertension focused on measuring (Poly)phenols, Aronia berry, Blood pressure, Vascular function

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Life Sciences and Medecine
  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Aronia extract

Arm Description

Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)

Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Office blood pressure
Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption
Heart rate
Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption
Flow-mediated dilation
Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption
Blood flow velocity
Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption
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
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
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
Blood cortisol
Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption
Number of volunteers with treatment-related adverse events
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
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

Full Information

First Posted
January 11, 2018
Last Updated
September 20, 2019
Sponsor
King's College London
Collaborators
Naturex-Dbs
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1. Study Identification

Unique Protocol Identification Number
NCT03434574
Brief Title
Aronia Berry Consumption on Blood Pressure
Acronym
ABP
Official Title
Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
September 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
Collaborators
Naturex-Dbs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Healthy
Keywords
(Poly)phenols, Aronia berry, Blood pressure, Vascular function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Arm Title
Aronia extract
Arm Type
Active Comparator
Arm Description
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aronia extract
Intervention Description
Powdered extract obtained from aronia berries (Aronia melanocarpa).
Primary Outcome Measure Information:
Title
Changes from baseline ambulatory blood pressure after 12-week consumption
Description
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
Secondary Outcome Measure Information:
Title
Office blood pressure
Description
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
Title
Heart rate
Description
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
Title
Flow-mediated dilation
Description
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
Title
Blood flow velocity
Description
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
Title
Pulse wave velocity (PWV)
Description
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
Title
Augmentation Index (AIx)
Description
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
Title
Blood lipids
Description
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
Title
Blood cortisol
Description
Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption
Time Frame
Baseline and 12 weeks
Title
Number of volunteers with treatment-related adverse events
Description
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Time Frame
Baseline and 12 weeks
Title
24-hour heart rate
Description
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
Other Pre-specified Outcome Measures:
Title
Plasma aronia berry (poly)phenol metabolites
Description
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
Title
Microbiome analysis
Description
Stool sample collection (Omnigene gut collection kit)
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Department of Life Sciences and Medecine
City
London
State/Province
Central London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
Facility Name
King's College London
City
London
State/Province
England
ZIP/Postal Code
SE1 9NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36228567
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.
Results Reference
derived

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Aronia Berry Consumption on Blood Pressure

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