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

King's College London

Status

Unknown

Conditions

Healthy

Treatments

Other: raspberry powder, milled flaxseed and soy milk

Study type

Interventional

Funder types

Other

Identifiers

NCT03573414

Stratification Study

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.