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

Healthy Clinical Trial

— StratiPol  

Official title:

Gut Microbial Metabolism of Polyphenols and Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573414
• Other study ID #: Stratification Study
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: King's College London
• Contact: Julia Casani-Cubel, MBBS
• Phone: +44 (0) 20 7848 4162
• Email: julia.casani[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	King's College London, Department of Nutritional Sciences	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Washington Red Raspberries Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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