Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)

NCT04087278 | Completed

• 1 other identifier: CHARM Study
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Cardiovascular system; Polyphenols

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in office blood pressure

  Baseline vs 12 weeks post-consumption

• Change in heart rate

  Baseline vs 12 weeks post-consumption

• Change in blood flow velocity

  Baseline vs 12 weeks post-consumption

• Change in pulse wave velocity (PWV)

  Baseline vs 12 weeks post-consumption

• Change in augmentation Index (AIx)

  Baseline vs 12 weeks post-consumption

Other Outcomes (7)

• Change in urinary metabolic (poly)phenol metabolite concentrations

  Baseline vs 12 weeks post-consumption

• Change in plasmatic metabolic (poly)phenol metabolite concentrations

  Baseline vs 12 weeks post-consumption

• Gut microbiome composition

  Baseline vs 12 weeks post-consumption

Study Arms (4)

Metabotype A

ACTIVE COMPARATOR

Taking treatment

Dietary Supplement: Red Raspberry Ellagitannin Extract

Metabotype B

ACTIVE COMPARATOR

Taking treatment

Dietary Supplement: Red Raspberry Ellagitannin Extract

Metabotype 0

ACTIVE COMPARATOR

Taking treatment

Dietary Supplement: Red Raspberry Ellagitannin Extract

Placebo

PLACEBO COMPARATOR

Taking matching placebo

Dietary Supplement: Matching Placebo

Interventions

Red Raspberry Ellagitannin Extract DIETARY_SUPPLEMENT

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

Metabotype 0; Metabotype A; Metabotype B

Matching Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Centro de Edafología y Biología Aplicada del Segura: collaborator
• Washington Red Raspberry Commission: collaborator

Study Sites (1)

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

London, SE1 9NH, United Kingdom

Location

Study Officials

• Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Nutritional Sciences

Model Details: Double-blind placebo randomized controlled trial

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 12, 2019
• Study Start: September 19, 2019
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)