Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
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 metabotypes (gut-microbial metabolic profile): UM-0, UM-A and
 UM-B.

 The investigators will evaluate changes in blood pressure, endothelial function, arterial
 stiffness, lipid profile, cognitive performance and gut microbiome composition.
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 improve vascular health. It has also been observed that the capacity of the
 gut microbiome to metabolize urolithins can influence the cardiometabolic response to
 ellagitannin consumption. In this work the investigators aim to investigate whether urolithin
 metabotypes (UM-A, B and 0) can influence the vascular response to a (poly)phenol-rich
 breakfast containing red raspberry ellagitannins in a healthy UK population.

 You will be stratified by metabotype in a first phase (NCT03573414) and are then randomly
 allocated to treatment or placebo. Outcomes are measured at baseline and after 12 weeks
 consumption of the study product.
Inclusion Criteria:

 -  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 Criteria:

 -  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.