Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects

This is an interventional other trial for Healthy focused on measuring endothelial function, healthy adults, grape and blueberry extracts, flavanol monomers Read More

Inclusion Criteria:

• Presenting at least two of the following risks of suboptimal endothelial function (but not under prescribed drug for this reason):
• Overweight, defined by: 25 ≤ BMI < 30 kg/m2;
• Central obesity defined according to IDE criteria (2009): for European subjects, waist circumference ≥ 94 cm (with a tolerance of -10%);
• High Normal Blood pressure defined according to ESC/ESH guidelines (2013): Systolic Blood Pressure ≥ 130 and ≤ 139 mmHg or Diastolic Blood Pressure ≥ 85 and ≤ 89 mmHg;
• Considered healthy based on their self-declaration and physical examination;
• Subjects capable of and willing to comply with the protocol and to give their written informed consent.
• Subjects affiliated with a social security scheme.

Non-inclusion Criteria:

• Metabolic abnormality or major cardiovascular risk factor, such as (but not limited to):
• clinically significant arrhythmia,
• diabetes mellitus (type I or II),
• chronic kidney disease.
• Consumption of food supplement(s) currently or within the past 4 weeks before entry into the study, such as but not limited to: botanicals, vitamins, minerals, amino acids;
• Smoking > 5 cigarettes/ day and > 5 pack-years for at least 2 years;
• Use of any type of medication currently or within 2 months before entry into the study (more especially antihypertensive drug);
• Use of any narcotic drug (including cannabis) within 2 months before entry into the study detected by the self-declaration of the participant and/ or by the urine THC test ;
• Endurance sport activities > 5 h/ week;
• Self-reported alcohol intake >10 units/ week (1 unit = 1 standard glass)
• Weight change > 5% of total body weight within the 3 months before V1;
• Currently under prescribed diet regimen, whatever the reason;
• Any intolerance or allergy documented or suspected to one of the components of the study products or to the Glyceryl trinitrate (GTN);
• Any contraindication to the GTN drug:
• severe hypotension,
• obstructive cardiomyopathy,
• myocardial infarction,
• intracranial hypertension,
• sildenafil intake (occasionally or regularly). .
• Subject presenting a psychological or linguistic inability to sign the informed consent;
• Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
• Subject participating in another biomedical study or participation in another study within the 3 months before entry into this study;
• Any regulatory reason according to national applicable regulation.

Exclusion criteria :

Volunteers whose fasting blood sample at V0 will reveal a pathological level of glycaemia (> 1,26 g/L) and/ or a dyslipidemia (example : triacylglycerol > 1,75 g/L) will be excluded.