Clinical trial NCT03573414: Gut Microbial Metabolism of Polyphenols and Cardiovascular Health (StratiPol) (Stratification Study)
Official title: Gut Microbial Metabolism of Polyphenols and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Cardiovascular system
Polyphenols
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Washington Red Raspberry Commission
First posted: 2018-06-29
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.
timeFrame: 1-3 days
Secondary outcomes:
measure: Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast.
timeFrame: Baseline 0 and 72 hours.
measure: Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast
timeFrame: Baseline 0 and 72 hours.
measure: Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast.
timeFrame: Baseline 0 and 72 hours.
measure: Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast.
timeFrame: Baseline 0 and 72 hours.
measure: Changes in heart rate after 3 days consumption of high polyphenol breakfast.
timeFrame: Baseline 0 and 72 hours.
measure: Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones.
timeFrame: Baseline 0 and 72 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London, Department of Nutritional Sciences
Study officials:
affiliation: ana.rodriguez-mateos@kcl.ac.uk
name: Dr. Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: