Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

Healthy Volunteers Clinical Trial

— CHARM  

Official title:

Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087278
• Other study ID #: CHARM Study
• Status: Completed
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: March 14, 2023

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Red Raspberry Ellagitannin Extract
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
• Matching Placebo
Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)

Locations

Country	Name	City	State
United Kingdom	Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Centro de Edafologia y Biologia Aplicada del Segura (CEBAS) - Consejo Superior de Investigaciones Cientificas (CSIC), Washington Red Raspberry Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in plasmatic metabolic (poly)phenol metabolite concentrations	Measured by liquid chromotography-mass spectrometry (LC/MS) at baseline and after 12 weeks	Baseline vs 12 weeks post-consumption
Other	Gut microbiome composition	Analysis of the microbiome composition and diversity at baseline and after 12 weeks post-consumption	Baseline vs 12 weeks post-consumption
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Change in heart rate	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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