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

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ClinicalTrials.gov Identifier: NCT03573414
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : October 22, 2021
Sponsor:
Collaborator:
Washington Red Raspberries Commission
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Other: raspberry powder, milled flaxseed and soy milk Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gut Microbial Metabolism of Polyphenols and Cardiovascular Health
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast. [ Time Frame: 1-3 days ]
    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.


Secondary Outcome Measures :
  1. Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast. [ Time Frame: Baseline 0 and 72 hours. ]
    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.

  2. Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast [ Time Frame: Baseline 0 and 72 hours. ]
    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.

  3. Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast. [ Time Frame: Baseline 0 and 72 hours. ]
    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.

  4. Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast. [ Time Frame: Baseline 0 and 72 hours. ]
    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.

  5. Changes in heart rate after 3 days consumption of high polyphenol breakfast. [ Time Frame: Baseline 0 and 72 hours. ]
    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.

  6. Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones. [ Time Frame: Baseline 0 and 72 hours ]
    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)


Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT03573414


Contacts
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Contact: Wafa Alotaibi, MSc 02078484162 wafa.alotaibi@kcl.ac.uk
Contact: Paul YOUNG TIE YANG, MSc 02078484162 paul.young_tie_yang@kcl.ac.uk

Locations
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United Kingdom
King's College London, Department of Nutritional Sciences Recruiting
London, United Kingdom, SE1 9NH
Contact: Dr. Ana Rodriguez-mateos, PhD       ana.rodriguez-mateos@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Washington Red Raspberries Commission
Investigators
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Principal Investigator: Dr. Ana Rodriguez-Mateos, PhD ana.rodriguez-mateos@kcl.ac.uk
More Information
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Responsible Party: Dr Ana Rodriguez-Mateos, Lecturer in Nutrition, King's College London
ClinicalTrials.gov Identifier: NCT03573414    
Other Study ID Numbers: Stratification Study
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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