HealthyNCT04697589

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

A study testing Memophenol 300 mg and Memophenol 600 mg in people with Healthy, run by Activ'inside at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Memophenol 300 mg and Memophenol 600 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteFrance
Study dates: 1 Feb 2021to 11 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

CIC Inserm 1405, University Hospital Clermont-Ferrand,
Clermont-Ferrand, 63003

Other trials in France

About this study

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

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
Being tested: Memophenol 300 mg, Memophenol 600 mg, Placebo
Keywords: endothelial function, healthy adults, grape and blueberry extracts, flavanol monomers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Memophenol 300 mgDietary supplement
300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Memophenol 600 mgDietary supplement
600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
PlaceboDietary supplement
Colored maltodextrin

Study groups in NCT04697589
Study group	Role	What they receive
SBRP 300 mg	Experimental	300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. Receives: Dietary Supplement: Memophenol 300 mg
SBRP 600 mg	Experimental	600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. Receives: Dietary Supplement: Memophenol 600 mg
Placebo	Placebo comparator	Colored maltodextrin Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Between Baseline (Before product intake) and 2 hours after product intake

Secondary outcomes (3)

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 .
Measured: Between Baseline (Before product intake) and 2 hours after product intake
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.
Measured: Between Baseline (Before product intake) and 2 hours after product intake
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.
Measured: Between Baseline (Before product intake) and 2 hours after product intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202111 Dec 2023

First posted6 Jan 2021
Study start1 Feb 2021
Primary completion11 Dec 2023
Study completion11 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04697589
Sponsor's protocol ID: FMD1-AI-2020
Status last verified: Feb 2024
First submitted: 5 Jan 2021
Last updated: 14 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04697589
Acronym / sponsor ID: FMD1-AI-2020
Conditions: Healthy
Keywords: endothelial function, healthy adults, grape and blueberry extracts, flavanol monomers
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Activ'insideIndustry (pharma, biotech, devices)
Collaborators: CIC Inserm 1405, University Hospital Clermont-Ferrand, France
Study start: 1 Feb 2021 (actual)
Primary completion: 11 Dec 2023 (actual)
Study completion: 11 Dec 2023 (actual)
First posted: 6 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SBRP 300 mg	Experimental	Dietary Supplement: Memophenol 300 mg300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
SBRP 600 mg	Experimental	Dietary Supplement: Memophenol 600 mg600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Placebo	Placebo comparator	Dietary Supplement: PlaceboColored maltodextrin

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (31 listed)

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;

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Memophenol 300 mg300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.	Dietary supplement	SBRP 300 mg
Memophenol 600 mg600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.	Dietary supplement	SBRP 600 mg
PlaceboColored maltodextrin	Dietary supplement	Placebo

Primary outcome

Change in endothelium-dependent flow-mediated dilation (ED-FMD)
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
ED-FMD : maximal change in the diameter of the brachial artery induced by increased flow, expressed in percentage (%) of the basal diameter.

3 secondary outcomes

Change in endothelium-independent vasodilation (EIVD)
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
Change in diastolic blood pressure
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
Change in systolic blood pressure
Time frame: Between Baseline (Before product intake) and 2 hours after product intake

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gisèle Pickering principal investigator

CIC Inserm 1405, University Hospital Clermont-Ferrand, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Memophenol 300 mg and Memophenol 600 mg in people with Healthy, run by Activ'inside at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in endothelium-dependent flow-mediated dilation (ED-FMD) (time frame: Between Baseline (Before product intake) and 2 hours after product intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04697589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.