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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
79
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, United Kingdom
Change in flow-mediated dilation (FMD)
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on flow-mediated dilation at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in office blood pressure
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in heart rate
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on heart rate, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in blood flow velocity
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on blood flow velocity at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in pulse wave velocity (PWV)
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in augmentation Index (AIx)
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in blood lipid concentrations
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Determine the effect of the Red raspberry ellagitannin extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in blood inflammatory markers (circulating concentrations)
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on blood inflammatory markers (CRP, IL-6), at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour heart rate
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour ambulatory blood pressure
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on 24-hour ambulatory blood pressure (SBP and DBP), using a monitor, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour AIx and PWV
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on 24-hour arterial stiffness (AIx and PWV), using a monitor, at 12 weeks post consumption
Time frame: Baseline vs 12 weeks post-consumption