Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
Primary Purpose
Healthy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Memophenol 300 mg
Memophenol 600 mg
Placebo
Sponsored by
About this trial
This is an interventional other trial for Healthy focused on measuring endothelial function, healthy adults, grape and blueberry extracts, flavanol monomers
Eligibility Criteria
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.
Sites / Locations
- CIC Inserm 1405, University Hospital Clermont-Ferrand,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SBRP 300 mg
SBRP 600 mg
Placebo
Arm Description
300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Colored maltodextrin
Outcomes
Primary Outcome Measures
Change in endothelium-dependent flow-mediated dilation (ED-FMD)
ED-FMD : maximal change in the diameter of the brachial artery induced by increased flow, expressed in percentage (%) of the basal diameter.
Secondary Outcome Measures
Change in endothelium-independent vasodilation (EIVD)
EIVD : Baseline diameter of the brachial artery will be assessed, and the increase in diameter of the brachial artery after application of glyceryl trinitrate will be measured .
Change in diastolic blood pressure
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
Change in systolic blood pressure
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
Full Information
NCT ID
NCT04697589
First Posted
January 5, 2021
Last Updated
April 12, 2023
Sponsor
Activ'inside
Collaborators
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
1. Study Identification
Unique Protocol Identification Number
NCT04697589
Brief Title
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
Official Title
Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects: Randomized, Cross-over, Double-blind Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Activ'inside
Collaborators
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 public health interest.
Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD) after a single dose. Grape is also a main source of flavanol monomers, that's why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake.
The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a grape extract and a blueberry extract. In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
endothelial function, healthy adults, grape and blueberry extracts, flavanol monomers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRP 300 mg
Arm Type
Experimental
Arm Description
300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Arm Title
SBRP 600 mg
Arm Type
Experimental
Arm Description
600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Colored maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Memophenol 300 mg
Intervention Description
300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Intervention Type
Dietary Supplement
Intervention Name(s)
Memophenol 600 mg
Intervention Description
600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Colored maltodextrin
Primary Outcome Measure Information:
Title
Change in endothelium-dependent flow-mediated dilation (ED-FMD)
Description
ED-FMD : maximal change in the diameter of the brachial artery induced by increased flow, expressed in percentage (%) of the basal diameter.
Time Frame
Between Baseline (Before product intake) and 2 hours after product intake
Secondary Outcome Measure Information:
Title
Change in endothelium-independent vasodilation (EIVD)
Description
EIVD : Baseline diameter of the brachial artery will be assessed, and the increase in diameter of the brachial artery after application of glyceryl trinitrate will be measured .
Time Frame
Between Baseline (Before product intake) and 2 hours after product intake
Title
Change in diastolic blood pressure
Description
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
Time Frame
Between Baseline (Before product intake) and 2 hours after product intake
Title
Change in systolic blood pressure
Description
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
Time Frame
Between Baseline (Before product intake) and 2 hours after product intake
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Macian
Phone
0473178406
Ext
+33
Email
n.macian@chu-clermondferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle Pickering
Organizational Affiliation
CIC Inserm 1405, University Hospital Clermont-Ferrand, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIC Inserm 1405, University Hospital Clermont-Ferrand,
City
Clermont-Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémy Evrard
12. IPD Sharing Statement
Learn more about this trial
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
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