Healthy VolunteersCHARMNCT04087278
Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
A study testing Red Raspberry Ellagitannin Extract in people with Healthy Volunteers, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Red Raspberry Ellagitannin Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2019to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, SE1 9NH
About this study
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.
Read the 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
- Being tested
- Red Raspberry Ellagitannin Extract, Matching Placebo
- Keywords
- Cardiovascular system, Polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Raspberry Ellagitannin ExtractDietary supplement
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)
Matching PlaceboDietary supplement
Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)
| Study group | Role | What they receive |
|---|---|---|
| Metabotype A | Active comparator | Taking treatment Receives: Dietary Supplement: Red Raspberry Ellagitannin Extract |
| Metabotype B | Active comparator | Taking treatment Receives: Dietary Supplement: Red Raspberry Ellagitannin Extract |
| Metabotype 0 | Active comparator | Taking treatment Receives: Dietary Supplement: Red Raspberry Ellagitannin Extract |
| Placebo | Placebo comparator | Taking matching placebo Receives: Dietary Supplement: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline vs 12 weeks post-consumption
Secondary outcomes (10)
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
Measured: Baseline vs 12 weeks post-consumption
Change in heart rate
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on heart rate, at 12 weeks post consumption
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
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
Measured: Baseline vs 12 weeks post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start19 Sep 2019
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Edafología y Biología Aplicada del Segura, Washington Red Raspberry Commission
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087278
- Sponsor's protocol ID
- CHARM Study
- Acronym
- CHARM
- Status last verified
- Oct 2023
- First submitted
- 2 Sep 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
- ClinicalTrials.gov ID
- NCT04087278
- Acronym / sponsor ID
- CHARM / CHARM Study
- Conditions
- Healthy Volunteers
- Keywords
- Cardiovascular system, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Centro de Edafología y Biología Aplicada del Segura, Washington Red Raspberry Commission
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind placebo randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Metabotype A | Active comparator | Dietary Supplement: Red Raspberry Ellagitannin ExtractTaking treatment |
| Metabotype B | Active comparator | Dietary Supplement: Red Raspberry Ellagitannin ExtractTaking treatment |
| Metabotype 0 | Active comparator | Dietary Supplement: Red Raspberry Ellagitannin ExtractTaking treatment |
| Placebo | Placebo comparator | Dietary Supplement: Matching PlaceboTaking matching placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Raspberry Ellagitannin ExtractPurified red raspberries ellagitannins extract 560 mg (4 capsules/day) | Dietary supplement | Metabotype 0, Metabotype A, Metabotype B |
| Matching PlaceboPlacebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day) | Dietary supplement | Placebo |
Primary outcome
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
10 secondary outcomes
Change in office blood pressure
Time frame: Baseline vs 12 weeks post-consumption
Change in heart rate
Time frame: Baseline vs 12 weeks post-consumption
Change in blood flow velocity
Time frame: Baseline vs 12 weeks post-consumption
Change in pulse wave velocity (PWV)
Time frame: Baseline vs 12 weeks post-consumption
Change in augmentation Index (AIx)
Time frame: Baseline vs 12 weeks post-consumption
Change in blood lipid concentrations
Time frame: Baseline vs 12 weeks post-consumption
Change in blood inflammatory markers (circulating concentrations)
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour heart rate
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour ambulatory blood pressure
Time frame: Baseline vs 12 weeks post-consumption
Change in 24-hour AIx and PWV
Time frame: Baseline vs 12 weeks post-consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rodriguez-Mateos, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Raspberry Ellagitannin Extract in people with Healthy Volunteers, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in flow-mediated dilation (FMD) (time frame: Baseline vs 12 weeks post-consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.