Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM) (CHARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087278
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborators:
CEBAS-CSIC Murcia
Washington Red Raspberries Commission
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Red Raspberry Ellagitannin Extract Dietary Supplement: Matching Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: Metabotype A
Taking treatment
Dietary Supplement: Red Raspberry Ellagitannin Extract
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Active Comparator: Metabotype B
Taking treatment
Dietary Supplement: Red Raspberry Ellagitannin Extract
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Active Comparator: Metabotype 0
Taking treatment
Dietary Supplement: Red Raspberry Ellagitannin Extract
Purified red raspberries ellagitannins extract 560 mg (4 capsules/day)

Placebo Comparator: Placebo
Taking matching placebo
Dietary Supplement: Matching Placebo
Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Change in blood inflammatory markers (circulating concentrations) [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Determine the effect of the Red raspberry ellagitannin extract vs Placebo on blood inflammatory markers (CRP, IL-6), at 12 weeks post consumption

  8. Change in 24-hour heart rate [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Determine the effect of the Red raspberry ellagitannin extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption

  9. 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

  10. 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


Other Outcome Measures:
  1. 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

  2. Change in plasmatic 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

  3. Gut microbiome composition [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Analysis of the microbiome composition and diversity at baseline and after 12 weeks post-consumption

  4. Change in verbal-episodic memory performance assessed by AVLT [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Assessment of the performance with the difference of words remembered between baseline and after 12 weeks post-consumption.

  5. Change in executive function performance assessed by the switching task [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Assessment of the performance calculating the difference in mistakes (not applying the right rule when needed) between baseline and after 12 weeks post-consumption.

  6. Change in visual-spatial working memory performance assessed by the Corsi task [ Time Frame: Baseline vs 12 weeks post-consumption ]
    Assessment of the performance with the difference in mistakes remembering the block patterns between baseline and after 12 weeks post-consumption.

  7. Change in mood using the PANAS questionnaire [ Time Frame: Baseline vs 12 weeks post-consumption ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087278


Contacts
Layout table for location contacts
Contact: Paul Young Tie Yang, MSc +44 (0) 20 7848 4162 paul.young_tie_yang@kcl.ac.uk
Contact: Ana Rodriguez-Mateos, PhD +44 (0)20 7848 4349 ana.rodriguez-mateos@kcl.ac.uk

Locations
Layout table for location information
United Kingdom
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London Recruiting
London, United Kingdom, SE1 9NH
Contact: Ana Rodriguez-Mateos, PhD    +44 (0)20 7848 4349    ana.rodriguez-mateos@kcl.ac.uk   
Sponsors and Collaborators
King's College London
CEBAS-CSIC Murcia
Washington Red Raspberries Commission
Investigators
Layout table for investigator information
Principal Investigator: Ana Rodriguez-Mateos, PhD King's College London

Layout table for additonal information
Responsible Party: Dr Ana Rodriguez-Mateos, Lecturer in Nutrition, King's College London
ClinicalTrials.gov Identifier: NCT04087278     History of Changes
Other Study ID Numbers: CHARM Study
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
Cardiovascular system
Polyphenols