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

NCT04697589 | Completed DMC

• 1 other identifier: FMD1-AI-2020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

endothelial function; healthy adults; grape and blueberry extracts; flavanol monomers

Outcome Measures

Primary Outcomes (1)

• 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.

  Between Baseline (Before product intake) and 2 hours after product intake

Secondary Outcomes (3)

• Change in endothelium-independent vasodilation (EIVD)

  Between Baseline (Before product intake) and 2 hours after product intake

• Change in diastolic blood pressure

  Between Baseline (Before product intake) and 2 hours after product intake

• Change in systolic blood pressure

  Between Baseline (Before product intake) and 2 hours after product intake

Study Arms (3)

SBRP 300 mg

EXPERIMENTAL

300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.

Dietary Supplement: Memophenol 300 mg

SBRP 600 mg

EXPERIMENTAL

600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.

Dietary Supplement: Memophenol 600 mg

Placebo

PLACEBO COMPARATOR

Colored maltodextrin

Dietary Supplement: Placebo

Interventions

Memophenol 300 mg DIETARY_SUPPLEMENT

300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.

SBRP 300 mg

Memophenol 600 mg DIETARY_SUPPLEMENT

600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.

SBRP 600 mg

Placebo DIETARY_SUPPLEMENT

Colored maltodextrin

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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 ;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Activ'inside: lead
• CIC Inserm 1405, University Hospital Clermont-Ferrand, France: collaborator

Study Sites (1)

CIC Inserm 1405, University Hospital Clermont-Ferrand,

Clermont-Ferrand, 63003, France

Location

Study Officials

• Gisèle Pickering

  CIC Inserm 1405, University Hospital Clermont-Ferrand, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: February 1, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

FR (1)