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

Study Overview
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Brief Summary
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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.

Official Title
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Gut Microbial Metabolism of Polyphenols and Cardiovascular Health

Conditions
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Healthy

Intervention / Treatment
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* Other: raspberry powder, milled flaxseed and soy milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy men and women<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular system, Polyphenols