Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

King's College London

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Matching Placebo; Dietary Supplement: Red Raspberry Ellagitannin Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04087278

CHARM Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 4 patient groups, including a placebo group

Metabotype A

Active Comparator group

Description:

Taking treatment

Treatment:

Dietary Supplement: Red Raspberry Ellagitannin Extract

Metabotype B

Active Comparator group

Description:

Taking treatment

Treatment:

Dietary Supplement: Red Raspberry Ellagitannin Extract

Metabotype 0

Active Comparator group

Description:

Taking treatment

Treatment:

Dietary Supplement: Red Raspberry Ellagitannin Extract

Placebo

Placebo Comparator group

Description:

Taking matching placebo

Treatment:

Dietary Supplement: Matching Placebo