- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087278
Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM) (CHARM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia Casani-Cubel, MBBS
- Phone Number: +44 (0) 20 7848 4162
- Email: julia.casani@kcl.ac.uk
Study Contact Backup
- Name: Ana Rodriguez-Mateos, PhD
- Phone Number: +44 (0)20 7848 4349
- Email: ana.rodriguez-mateos@kcl.ac.uk
Study Locations
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-
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London, United Kingdom, SE1 9NH
- Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metabotype A
Taking treatment
|
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
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Active Comparator: Metabotype B
Taking treatment
|
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
|
Active Comparator: Metabotype 0
Taking treatment
|
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
|
Placebo Comparator: Placebo
Taking matching placebo
|
Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in flow-mediated dilation (FMD)
Time Frame: Baseline vs 12 weeks post-consumption
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in office blood pressure
Time Frame: Baseline vs 12 weeks post-consumption
|
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
Time Frame: Baseline vs 12 weeks post-consumption
|
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
Time Frame: Baseline vs 12 weeks post-consumption
|
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)
Time Frame: Baseline vs 12 weeks post-consumption
|
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)
Time Frame: Baseline vs 12 weeks post-consumption
|
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
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Change in blood lipid concentrations
Time Frame: Baseline vs 12 weeks post-consumption
|
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
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Baseline vs 12 weeks post-consumption
|
Change in blood inflammatory markers (circulating concentrations)
Time Frame: Baseline vs 12 weeks post-consumption
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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
Time Frame: Baseline vs 12 weeks post-consumption
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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
Time Frame: Baseline vs 12 weeks post-consumption
|
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
Time Frame: Baseline vs 12 weeks post-consumption
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in urinary metabolic (poly)phenol metabolite concentrations
Time Frame: Baseline vs 12 weeks post-consumption
|
Measured by liquid chromotography-mass spectrometry (LC/MS) at baseline and after 12 weeks in a 24h urine sample
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Baseline vs 12 weeks post-consumption
|
Change in plasmatic metabolic (poly)phenol metabolite concentrations
Time Frame: Baseline vs 12 weeks post-consumption
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Measured by liquid chromotography-mass spectrometry (LC/MS) at baseline and after 12 weeks
|
Baseline vs 12 weeks post-consumption
|
Gut microbiome composition
Time Frame: Baseline vs 12 weeks post-consumption
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Analysis of the microbiome composition and diversity at baseline and after 12 weeks post-consumption
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Baseline vs 12 weeks post-consumption
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Change in verbal-episodic memory performance assessed by AVLT
Time Frame: Baseline vs 12 weeks post-consumption
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Assessment of the performance with the difference of words remembered between baseline and after 12 weeks post-consumption.
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Baseline vs 12 weeks post-consumption
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Change in executive function performance assessed by the switching task
Time Frame: Baseline vs 12 weeks post-consumption
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Assessment of the performance calculating the difference in mistakes (not applying the right rule when needed) between baseline and after 12 weeks post-consumption.
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Baseline vs 12 weeks post-consumption
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Change in visual-spatial working memory performance assessed by the Corsi task
Time Frame: Baseline vs 12 weeks post-consumption
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Assessment of the performance with the difference in mistakes remembering the block patterns between baseline and after 12 weeks post-consumption.
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Baseline vs 12 weeks post-consumption
|
Change in mood using the PANAS questionnaire
Time Frame: Baseline vs 12 weeks post-consumption
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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.
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Baseline vs 12 weeks post-consumption
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Rodriguez-Mateos, PhD, King's College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHARM Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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