HealthyNCT03508206
Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students
A study testing SBRP in people with Healthy, run by Activ'inside at 1 site in France.
Trial summary
Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SBRP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2017to 31 Jul 2018
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Graduate students (being either at the University or high school), with exam at least every 6 months and attending courses at the equivalent of at least 2 full days each week;
- Male and female subjects (at least 25% of each gender);
- Subjects aged 18 - 25 years (limits included);
- French native speaker;
- Healthy, and especially not suffering from the following diseases, either medically controlled or not:
- depression,
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- anxiety disorders,
- diabetes (type I or type II),
- dyslipidemia,
- hypertension,
- any other cardiovascular disease,
- disorder of the thyroid function.
- Not consuming any food supplements (at time of V0 visit) and agreeing not to consume any food supplements until the end of the study;
- No consumption within the last 30 days (30 days before the V0 visit) of drug or food supplement likely to affect the studied parameters,
- Body Mass Index (BMI) < 30 kg/m2;
- Non-smoker;
- No use of narcotics nor cannabis within the last 7 days (the 7 days preceding the V0 visit) and agreeing not to consume such products until the end of the study. The compliance with this criteria will be confirmed by a urine TetraHydroCannabinol (THC) test at the beginning of the testing visits (V1 and V2);
- Subjects capable of and willing to comply with the protocol and to give their written informed consent.
Who cannot join
- Exam during the study period;
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg during the V0 visit;
- Currently suffering from or personal history of psychiatric or neurologic disorders (examples: schizophrenia, depression, generalized anxiety disorder, epilepsia) according to the subject's self-declaration;
- Neuroleptic, hypnotic, anxiolytic or antidepressant treatment (whatever the reason) ongoing or stopped since less than 3 months;
- Anti-hypertensive, blood thinner or anticoagulant treatment (eg aspirin > 325mg / day and prescribed as anticoagulant) ongoing or stopped since less than 3 months;
- Venotonic treatment or vasodilator treatment ongoing or stopped since less than 3 months;
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- Any other treatment (administered systemically or locally) that may affect the endothelial function (example: statins);
- History of moderate to severe traumatic brain injury and / or intracranial surgery;
- Personal history of Cerebrovascular Accident (CVA);
- Inflammatory bowel disease (examples: Crohn disease, coeliac disease, irritable bowel syndrome) likely to affect the intestinal absorption of the study product components;
- Progressive disease ongoing or resolved since less than one year;
- General anesthesia in the last 7 days or planned in the next 2 weeks;
- Restrictive or unbalanced diet (hypocaloric diet aiming at weight loss, vegan, …) according to the subject's self-declaration at V0;
- Excessive alcohol consumption : more than 2 glasses per day every day;
- Documented food allergy to one of the components of the study product;
- Psychological or linguistic incapability to sign the informed consent;
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Participation in another biomedical study or during the exclusion period of a previous study;
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students: Randomized, Placebo-controlled, Double-blind, Cross-over Clinical Trial
Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement.
The objective of this study is to investigate the effect of a Standardized botanical blend rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in healthy students. Moreover, 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.
The study design will be a double-blind, randomised, placebo controlled, crossover study. A total of 30 healthy volunteers will be included. Each participant will receive a single dose of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced order. There will be a 1 week washout period between the 2 experimental visits. During each experimental visit, after a training battery volunteers will be administered a cognitive test battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90 min post-dose to 160 min post-dose).
- Conditions
- Healthy
- Being tested
- SBRP, PLACEBO
- Keywords
- Students, cognitive functions, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRPDietary supplement
SBRP capsules
PLACEBODietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| SBRP arm | Experimental | Food supplement in hard gelatin capsule form containing a Standardized botanical blend rich in polyphenols (SBRP) Receives: Dietary Supplement: SBRP |
| Placebo arm | Placebo comparator | Hard gelatin capsule form containing maltodextrin, with the same appearance as SBRP capsules Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in the number of correct answers during the Serial Three Subtraction task (Serial Three) between the baseline battery and the 4th repetition of the battery after product intake (B4).
The Serial Three task will be administered through the computerized COMPASS battery (" Computerised Mental Performance Assessment System "). Serial subtraction tasks rely on working memory (executive function).
Measured: From baseline to 120 min post-dose
Secondary outcomes (17)
Changes in the number of correct responses from the Serial Three Subtraction task between the baseline battery and each of the repetitions N°1, 2, 3, 5 and 6 of the battery after product intake
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the number of correct responses from the Serial Three Subtraction task between the first repetition after product intake and the repetitions N°2 to 6
Differences between the values obtained during the first post-dose battery and the next repetitions;
Measured: From 90 to 160 min post-dose
Changes in the number of errors from the Serial Three Subtraction task (Serial Three, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the number of correct responses from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the number of errors from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the reaction time from the RVIP test (" Rapid Visual Information Processing ", COMPASS battery), in milliseconds (ms) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the percentage of correct responses from the RVIP test (COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the number of false alarms from the RVIP test (COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the score of mental fatigue (COMPASS battery self-assessment using a Visual Analogue Scale) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the score of anxiety (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the score of vigilance/ alertness (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Changes in the score of cognitive performances (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Differences between each battery and baseline values;
Measured: From baseline to 160 min post-dose
Number of correct responses at the immediate free recall test before the first repetition of the test battery (B1) ;
Number of words properly recalled, among a list of 20 words, with no clue
Measured: 85-90 min post-dose
Number of correct responses at the delayed free recall test, after the last repetition of the test battery (B6) ;
Number of words properly recalled, among a list of 20 words, with no clue
Measured: 165-170 min post-dose
Number of correct responses at the delayed recognition task, after the last repetition of the test battery (B6) ;
Number of words properly recognized among a list of 20 words containing 10 words from the original list and 10 distractors
Measured: 165-170 min post-dose
Changes between the values measured in fasting conditions and those measured after the end of the cognitive assessments in flow-mediated dilation (FMD)
Post-ischemic increase of brachial artery diameter, in % of the pre-ischemic diameter
Measured: Before product administration; 180 min post-dose
Changes between the values measured in fasting conditions and those measured after the end of the cognitive assessments (i.e. 3 hours after product intake) in basal diameter of brachial artery;
Pre-ischemic diameter of brachial artery (mm)
Measured: Before product administration; 180 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start13 Nov 2017
- Primary completion3 May 2018
- Study completion31 Jul 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC SANPSY (USR CNRS 3413), Hôpital Pellegrin, Bordeaux, FRANCE, Hospital St André, Bordeaux, FRANCE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508206
- Sponsor's protocol ID
- STUAI2017
- Status last verified
- May 2019
- First submitted
- 16 Apr 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students: Randomized, Placebo-controlled, Double-blind, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT03508206
- Acronym / sponsor ID
- STUAI2017
- Conditions
- Healthy
- Keywords
- Students, cognitive functions, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Collaborators
- CIC SANPSY (USR CNRS 3413), Hôpital Pellegrin, Bordeaux, FRANCE, Hospital St André, Bordeaux, FRANCE
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 25 Apr 2018 (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.
Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement.
The objective of this study is to investigate the effect of a Standardized botanical blend rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in healthy students. Moreover, 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.
The study design will be a double-blind, randomised, placebo controlled, crossover study. A total of 30 healthy volunteers will be included. Each participant will receive a single dose of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced order. There will be a 1 week washout period between the 2 experimental visits. During each experimental visit, after a training battery volunteers will be administered a cognitive test battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90 min post-dose to 160 min post-dose).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRP arm | Experimental | Dietary Supplement: SBRPFood supplement in hard gelatin capsule form containing a Standardized botanical blend rich in polyphenols (SBRP) |
| Placebo arm | Placebo comparator | Dietary Supplement: PLACEBOHard gelatin capsule form containing maltodextrin, with the same appearance as SBRP capsules |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Graduate students (being either at the University or high school), with exam at least every 6 months and attending courses at the equivalent of at least 2 full days each week;
- Male and female subjects (at least 25% of each gender);
- Subjects aged 18 - 25 years (limits included);
- French native speaker;
- Healthy, and especially not suffering from the following diseases, either medically controlled or not:
Key exclusion criteria (19 listed)
- Exam during the study period;
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg during the V0 visit;
- Currently suffering from or personal history of psychiatric or neurologic disorders (examples: schizophrenia, depression, generalized anxiety disorder, epilepsia) according to the subject's self-declaration;
- Neuroleptic, hypnotic, anxiolytic or antidepressant treatment (whatever the reason) ongoing or stopped since less than 3 months;
- Anti-hypertensive, blood thinner or anticoagulant treatment (eg aspirin > 325mg / day and prescribed as anticoagulant) ongoing or stopped since less than 3 months;
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 |
|---|---|---|
| SBRPSBRP capsules | Dietary supplement | SBRP arm |
| PLACEBOPlacebo capsules | Dietary supplement | Placebo arm |
Primary outcome
The primary endpoint is the change in the number of correct answers during the Serial Three Subtraction task (Serial Three) between the baseline battery and the 4th repetition of the battery after product intake (B4).
Time frame: From baseline to 120 min post-dose
The Serial Three task will be administered through the computerized COMPASS battery (" Computerised Mental Performance Assessment System "). Serial subtraction tasks rely on working memory (executive function).
17 secondary outcomes
Changes in the number of correct responses from the Serial Three Subtraction task between the baseline battery and each of the repetitions N°1, 2, 3, 5 and 6 of the battery after product intake
Time frame: From baseline to 160 min post-dose
Changes in the number of correct responses from the Serial Three Subtraction task between the first repetition after product intake and the repetitions N°2 to 6
Time frame: From 90 to 160 min post-dose
Changes in the number of errors from the Serial Three Subtraction task (Serial Three, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the number of correct responses from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the number of errors from the Serial Sevens Subtraction task (Serial Sevens, COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the reaction time from the RVIP test (" Rapid Visual Information Processing ", COMPASS battery), in milliseconds (ms) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the percentage of correct responses from the RVIP test (COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the number of false alarms from the RVIP test (COMPASS battery) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the score of mental fatigue (COMPASS battery self-assessment using a Visual Analogue Scale) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the score of anxiety (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the score of vigilance/ alertness (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Changes in the score of cognitive performances (COMPASS battery, VAS) between the baseline battery and each of the repetitions of the battery after product intake (B1 to B6);
Time frame: From baseline to 160 min post-dose
Number of correct responses at the immediate free recall test before the first repetition of the test battery (B1) ;
Time frame: 85-90 min post-dose
Number of correct responses at the delayed free recall test, after the last repetition of the test battery (B6) ;
Time frame: 165-170 min post-dose
Number of correct responses at the delayed recognition task, after the last repetition of the test battery (B6) ;
Time frame: 165-170 min post-dose
Changes between the values measured in fasting conditions and those measured after the end of the cognitive assessments in flow-mediated dilation (FMD)
Time frame: Before product administration; 180 min post-dose
Changes between the values measured in fasting conditions and those measured after the end of the cognitive assessments (i.e. 3 hours after product intake) in basal diameter of brachial artery;
Time frame: Before product administration; 180 min post-dose
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 29 May 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRP 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 18 inclusion and 19 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 29 May 2019. 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?
The primary endpoint is the change in the number of correct answers during the Serial Three Subtraction task (Serial Three) between the baseline battery and the 4th repetition of the battery after product intake (B4). (time frame: From baseline to 120 min post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2019.