Status:
COMPLETED
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
Lead Sponsor:
Activ'inside
Collaborating Sponsors:
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of pu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04697589
Start Date
February 1 2021
End Date
December 11 2023
Last Update
February 14 2024
Active Locations (1)
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1
CIC Inserm 1405, University Hospital Clermont-Ferrand,
Clermont-Ferrand, France, 63003