Status:
COMPLETED
Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
Lead Sponsor:
King's College London
Collaborating Sponsors:
Centro de Edafología y Biología Aplicada del Segura
Washington Red Raspberry Commission
Conditions:
Healthy Volunteers
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
In this study, the investigators aim to determine the health benefits of red raspberry ellagitannin consumption on cardiovascular health. The study population is stratified according to the urolithin ...
Detailed Description
Red raspberries are a good source of polyphenols including ellagitannins. Previous work suggests that urolithins, gut microbial metabolites derived from ellagitannins contained in raspberries, can imp...
Eligibility Criteria
Inclusion
- Healthy men or women aged 20-70 years old
- BMI between 18.5-35 kg/m²
- Normotensive: SBP lower than 140 mmHg or DBP lower than 90 mmHg
- Willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Able to understand the nature of the study
- Able to give signed written informed consent
Exclusion
- Have required treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs)
- BMI outside range
- Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Currently treated with a diet
- Chronic-acute disease
- Unstable psychological condition
- Diabetes mellitus, metabolic syndrome, acute inflammation, terminal renal failure, malignancies or abnormal heart rhythm (lower or higher than 60-100 bpm)
- History of cancer, myocardial infarction, cerebrovascular incident or kidney abnormality
- Allergies to berries, flax seeds and soy milk or other significant food allergy
- Requiring chronic antimicrobial or antiviral treatment
- Reported having taken food supplements, dietary supplement or herbal remedies within 1 month of study start
- Weight loss of more than 10% body weight in the previous 6 months
- Reported participant in another study within one month before the study start
- Smoke an irregular amount of cigarettes per day or planning to quit smoking in the next 3 months
- Unable to tolerate breakfast ingestion
- Pregnant woman/ lactating woman/ woman planning to become pregnant/ premenopausal women who do not have a regular menstrual cycle/ premenopausal women who do not have 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
- Unable to swallow the capsule.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04087278
Start Date
September 19 2019
End Date
March 14 2023
Last Update
November 1 2023
Active Locations (1)
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1
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, United Kingdom, SE1 9NH