Gut Microbial Metabolism of Polyphenols and Cardiovascular Health (StratiPol) (Stratification Study) (StratiPol)

Gut Microbial Metabolism of Polyphenols and Cardiovascular Health

There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. The objective of this study is to investigate the association between polyphenol microbiota metabolism and cardiovascular health.

The participants (n=250) with age range between 20 to 70 years old health overweight men and women. The participants will consume a polyphenol rich breakfast for three days (consisting on milled flaxseed, raspberry powder and soy milk). The participants will provide the investigators with urine and blood samples for polyphenol analysis. Cardiovascular measurements such as PWV, AIx, Blood Pressure and FMD will be performed at baseline and after 72h.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: raspberry powder, milled flaxseed and soy milk

• Study Type: Interventional
• Enrollment (Anticipated): 250
• 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: Paul YOUNG TIE YANG, MSc; Phone Number: 02078484162; Email: paul.young_tie_yang@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Recruiting
    • King's College London, Department of Nutritional Sciences
    • Contact: Dr. Ana Rodriguez-mateos, PhD; Email: ana.rodriguez-mateos@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy men and women aged 20-70 years
• BMI between 18.5 and 35 kg/m2
• Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
• Are able to understand the nature of the study
• Able to give signed written informed consent
• Signed informed consent form

Exclusion Criteria:

• Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
• Hypertensive, defined as 140/90mmHg or higher
• Obese participants with BMI superior or equal to 35 kg/m2
• Underweight participants defined by a BMI inferior to 18.5 kg/m2
• Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
• Abnormal heart rhythm (lower or higher than 60-100 bpm)
• Allergies to berries or other significant food allergy
• Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
• Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
• Subjects who reported participant in another study within one month before the study start
• Subjects who smoke an irregular amount of cigarettes per day
• Pregnant women or planning to become pregnant in the next 6 months
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy men and women; Intervention: 2*breakfast containing 40 g of raspberry powder, 30 g milled flax seeds and 250 mL of soy Milk.	Other: raspberry powder, milled flaxseed and soy milk; The participants will consume a breakfast consisting of 30 g of milled flaxseed, 40 g of raspberry powder and 250 ml of soy milk for 3 days; The participants will provide blood and urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.	To examine ellagitannins, lignans and isoflavones metabolites levels in urine and plasma assessed by liquid chromatography - mass spectrometer (LCMS) post 3 days consumption of high polyphenol breakfast contain 40 g raspberry powder, 30 g milled flaxseed and 250 mL soy milk to establish metabotypes.	1-3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast.	Determine the effect post 3 day consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on endothelium-dependent flow mediated dilation (FMD) of the brachial artery, including diameter and flow velocity using Ultra sound device.	Baseline 0 and 72 hours.
Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast	Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on arterial stiffness measured as pulse wave velocity (PWV) using a Sphygmocor device.	Baseline 0 and 72 hours.
Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast.	Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on arterial stiffness measured Augmentation index ( AIX) using a Sphygmocor device.	Baseline 0 and 72 hours.
Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast.	Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on central and peripheral systolic and diastolic blood pressure.	Baseline 0 and 72 hours.
Changes in heart rate after 3 days consumption of high polyphenol breakfast.	Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on heart rate.	Baseline 0 and 72 hours.
Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones.	Determine the bioavailability of polyphenols post 3 days of consumption of a polyphenol rich breakfast in blood and urine samples measured by liquid chromatograph - mass spectrometry (LCMS)	Baseline 0 and 72 hours

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Washington Red Raspberries Commission
• Investigators: Principal Investigator: Dr. Ana Rodriguez-Mateos, PhD, ana.rodriguez-mateos@kcl.ac.uk

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2018
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Polyphenols; Cardiovascular system
• Other Study ID Numbers: Stratification Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No