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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2022-09-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy men and women

Intervention:

2\*breakfast containing 40 g of raspberry powder, 30 g milled flax seeds and 250 mL of soy Milk.

Group Type EXPERIMENTAL

raspberry powder, milled flaxseed and soy milk

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type OTHER

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes