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| Name | Class |
|---|---|
| Centro de EdafologÃa y BiologÃa Aplicada del Segura | OTHER_GOV |
| Washington Red Raspberry Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabotype A | Active Comparator | Taking treatment |
|
| Metabotype B | Active Comparator | Taking treatment |
|
| Metabotype 0 | Active Comparator | Taking treatment |
|
| Placebo | Placebo Comparator | Taking matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Raspberry Ellagitannin Extract | Dietary Supplement | Purified red raspberries ellagitannins extract 560 mg (4 capsules/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline vs 12 weeks post-consumption |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline vs 12 weeks post-consumption |
| Change in heart rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary metabolic (poly)phenol metabolite concentrations | Measured by liquid chromotography-mass spectrometry (LC/MS) at baseline and after 12 weeks in a 24h urine sample | Baseline vs 12 weeks post-consumption |
| Change in plasmatic metabolic (poly)phenol metabolite concentrations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Rodriguez-Mateos, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London | London | SE1 9NH | United Kingdom |
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Double-blind placebo randomized controlled trial
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| Matching Placebo | Dietary Supplement | Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day) |
|
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on heart rate, at 12 weeks post consumption
| 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 | 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 | 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 | Baseline vs 12 weeks post-consumption |
| Change in blood lipid concentrations | 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 | 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 | 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 | 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 | 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 | Baseline vs 12 weeks post-consumption |
Measured by liquid chromotography-mass spectrometry (LC/MS) at baseline and after 12 weeks |
| Baseline vs 12 weeks post-consumption |
| Gut microbiome composition | Analysis of the microbiome composition and diversity at baseline and after 12 weeks post-consumption | Baseline vs 12 weeks post-consumption |
| Change in verbal-episodic memory performance assessed by AVLT | Assessment of the performance with the difference of words remembered between baseline and after 12 weeks post-consumption. | Baseline vs 12 weeks post-consumption |
| Change in executive function performance assessed by the switching task | Assessment of the performance calculating the difference in mistakes (not applying the right rule when needed) between baseline and after 12 weeks post-consumption. | Baseline vs 12 weeks post-consumption |
| Change in visual-spatial working memory performance assessed by the Corsi task | Assessment of the performance with the difference in mistakes remembering the block patterns between baseline and after 12 weeks post-consumption. | Baseline vs 12 weeks post-consumption |
| Change in mood using the PANAS questionnaire | Assessment of the change in the mood using the PANAS questionnaire containing 10 positive affects and 10 negative affects rated using a 5-point likert scale that ranges from "(1) Not at all to (5) Extremely", between baseline and after 12 weeks post-consumption. | Baseline vs 12 weeks post-consumption |