Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

NCT ID: NCT04087278

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2023-03-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Metabotype A

Taking treatment

Group Type: ACTIVE_COMPARATOR

Red Raspberry Ellagitannin Extract

Intervention Type: DIETARY_SUPPLEMENT

Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Metabotype B

Taking treatment

Group Type: ACTIVE_COMPARATOR

Red Raspberry Ellagitannin Extract

Intervention Type: DIETARY_SUPPLEMENT

Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Metabotype 0

Taking treatment

Group Type: ACTIVE_COMPARATOR

Red Raspberry Ellagitannin Extract

Intervention Type: DIETARY_SUPPLEMENT

Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Placebo

Taking matching placebo

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)

Interventions

Red Raspberry Ellagitannin Extract

Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Intervention Type: DIETARY_SUPPLEMENT

Matching Placebo

Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Edafología y Biología Aplicada del Segura

OTHER_GOV

Sponsor Role: collaborator

Washington Red Raspberry Commission

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Dr Ana Rodriguez-Mateos

Reader in Nutritional Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Rodriguez-Mateos, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CHARM Study

Identifier Type: -

Identifier Source: org_study_id