NCT04087278

Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Red Raspberry Ellagitannin Extract	Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
DIETARY_SUPPLEMENT	Matching Placebo	Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)

Timeline

• Start date: 2019-09-19
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2019-09-12
• Last updated: 2023-11-01

Locations

1 site across 1 country: United Kingdom