Status:
COMPLETED
Aronia Berry Consumption on Blood Pressure
Lead Sponsor:
King's College London
Collaborating Sponsors:
Naturex-Dbs
Conditions:
Prehypertension
Healthy
Eligibility:
All Genders
40-70 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03434574
Start Date
February 20 2018
End Date
September 12 2019
Last Update
September 23 2019
Active Locations (2)
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1
Department of Life Sciences and Medecine
London, Central London, United Kingdom, SE1 9NH
2
King's College London
London, England, United Kingdom, SE1 9NH