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Trial record 19 of 82 for:    extract | maltodextrin

Aronia Berry Consumption on Blood Pressure (ABP)

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ClinicalTrials.gov Identifier: NCT03434574
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Naturex-Dbs
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

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.


Condition or disease Intervention/treatment Phase
Prehypertension Healthy Dietary Supplement: Placebo Dietary Supplement: Aronia extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : September 12, 2019
Actual Study Completion Date : September 12, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Dietary Supplement: Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Active Comparator: Aronia extract
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Dietary Supplement: Aronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Office blood pressure [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption

  2. Heart rate [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption

  3. Flow-mediated dilation [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption

  4. Blood flow velocity [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption

  5. Pulse wave velocity (PWV) [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption

  6. Augmentation Index (AIx) [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Determine the effect of the Aronia extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption

  7. Blood lipids [ Time Frame: Baseline and 12 weeks ]
    Determine the effect of the Aronia extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption

  8. Blood cortisol [ Time Frame: Baseline and 12 weeks ]
    Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption

  9. Number of volunteers with treatment-related adverse events [ Time Frame: Baseline and 12 weeks ]
    The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.

  10. 24-hour heart rate [ Time Frame: Baseline and 12 weeks ]
    Determine the effect of the Aronia extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption


Other Outcome Measures:
  1. Plasma aronia berry (poly)phenol metabolites [ Time Frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours ]
    Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption at day 1 (baseline) and after 12 weeks.

  2. Microbiome analysis [ Time Frame: Baseline and 12 weeks ]
    Stool sample collection (Omnigene gut collection kit)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434574


Locations
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United Kingdom
Department of Life Sciences and Medecine
London, Central London, United Kingdom, SE1 9NH
King's College London
London, England, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Naturex-Dbs

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Responsible Party: Dr Ana Rodriguez-Mateos, Principal investigator, King's College London
ClinicalTrials.gov Identifier: NCT03434574     History of Changes
Other Study ID Numbers: Aronia BP
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
(Poly)phenols
Aronia berry
Blood pressure
Vascular function
Additional relevant MeSH terms:
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Prehypertension
Vascular Diseases
Cardiovascular Diseases