Healthy SubjectsBioMindNCT05472285
Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors
A study testing Verum in people with Healthy Subjects, run by Robertet SA at 2 sites in France.
Trial summary
The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the improvement of cognitive functions in healthy seniors with or without mild cognitive decline. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Verum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesFrance
- Study dates
- 23 May 2022to 23 May 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 55 and 70 years (limits included),
- Subjects with mild cognitive decline (MMSE between 21 and 24, including bounds) and healthy (MMSE >24 to 30).
- Subject with a Hamilton Anxiety Scale score between 5 and 17 (limits included),
- BMI between 18.5 and 29.5 kg/m² (limits included),
- Menopausal woman without hormone replacement therapy (at least 12 months without menstruation),
- Stable diet for at least 3 months,
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- Blood pressure below 14/90 mm HG,
- With no significant change in dietary habits or physical activity during the 3 months preceding randomization and agreeing to maintain them unchanged throughout the study,
- Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme,
- Agree to be registered on the volunteers in biomedical research file.
Who cannot join
- Suffering from a metabolic disorder such as diabetes treated or not, uncontrolled thyroidal trouble or other metabolic disorder,
- Suffering from a serious chronic disease (cancer (ongoing and if in remission for less than 5 years), HIV, renal failure, ongoing biliary or liver disorder, psychiatric pathologies (bi-polar disorders, depression, degenerative brain diseases (Alzheimer, vascular dementia, etc.), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with driving the vehicle. ), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with the conduct of the study by the investigator (e.g. celiac disease, Crohn's disease, irritable bowel disease, etc.).
- For Women: Non-menopausal woman or menopausal woman with hormone replacement therapy
- Consuming more than 5 cigarettes per day,
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- Under antioxidant treatment (vitamin A, C, E, β-carotene, lutein, lycopene, selenium, Ginkgo biloba, dehydroepiandrosterone, polyphenol in the broad sense, phytoestrogen, ...), sedative drugs (neuroleptics, benzodiazepines, anxiolytics, hypnotics) and related drugs, antidepressants, antipsychotics, mood stabilizers, (hypnotic anti-histamines... ), cognitive treatment or dietary supplements that could affect the parameters monitored during the study in the opinion of the investigator or in the month preceding the V1 visit.
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- Volunteer consuming no more than 400mg/d of total caffeine in a day (addition of beverages such as coffee, tea, energy drinks and soft drinks), [6 espressos = 162mg of caffeine and 4 mugs of filter coffee = 380mg, 8 cups of black tea = 360mg].
- Having a consumption of herbal infusions or waters > 2 liters / day
- Presenting a high probability of non-compliance with the protocol or of dropping out during the study (geographical instability, insufficient motivation, psychological profile, etc),
- Drinking more than 2 glasses of alcohol per day, every day and without interruption, and not willing to keep their drinking habits unchanged throughout the study
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinical Investigation Unit Biofortis - Paris
Paris, 75012
Clinical Investigation Unit of Biofortis - SHE
Saint-Herblain, 44800
About this study
Official title: Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors: a Randomized Double-blind Study Versus Placebo
The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the improvement of cognitive functions in healthy seniors with or without mild cognitive decline.
- Conditions
- Healthy Subjects
- Being tested
- Verum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerumDietary supplement
After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).
PlaceboDietary supplement
After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | 2 capsules per day during 8 weeks Receives: Dietary Supplement: Verum |
| Placebo | Placebo comparator | 2 capsules per day during 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mental fatigue
Mental fatigue is assessed twice on a VAS (Visual Analogue Scale) in the COMPASS test, which is a computerized test assessing cognitive functions. The first VAS is assessed following the cognitive Demand Battery comprising 3 tasks, namely a 3s serial subtraction task, a 7s serial subtraction task and another COMPASS task called Digit vigilance.
Measured: up to 10 weeks
Secondary outcomes (3)
Evolution of global cognitive functioning
Assessed with MMSE score
Measured: up to 10 weeks
Evolution of cognitive function
Assessed with COMPASS score
Measured: up to 10 weeks
The frequency of adverse events
The frequency of subjects with at least one AE (Adverse Event), SAE (Serious Adverse Event), treatment-emergent AE and treatment-emergent SAE and the number of corresponding events
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start23 May 2022
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Model description
- This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robertet SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472285
- Sponsor's protocol ID
- 2021-A02122-39
- Acronym
- BioMind
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors: a Randomized Double-blind Study Versus Placebo
- ClinicalTrials.gov ID
- NCT05472285
- Acronym / sponsor ID
- BioMind / 2021-A02122-39
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Robertet SAIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 25 Jul 2022 (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.
The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the improvement of cognitive functions in healthy seniors with or without mild cognitive decline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Dietary Supplement: Verum2 capsules per day during 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules per day during 8 weeks |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 55 and 70 years (limits included),
- Subjects with mild cognitive decline (MMSE between 21 and 24, including bounds) and healthy (MMSE >24 to 30).
- Subject with a Hamilton Anxiety Scale score between 5 and 17 (limits included),
- BMI between 18.5 and 29.5 kg/m² (limits included),
- Menopausal woman without hormone replacement therapy (at least 12 months without menstruation),
Key exclusion criteria (15 listed)
- Suffering from a metabolic disorder such as diabetes treated or not, uncontrolled thyroidal trouble or other metabolic disorder,
- Suffering from a serious chronic disease (cancer (ongoing and if in remission for less than 5 years), HIV, renal failure, ongoing biliary or liver disorder, psychiatric pathologies (bi-polar disorders, depression, degenerative brain diseases (Alzheimer, vascular dementia, etc.), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with driving the vehicle. ), immunodeficiency, uncontrolled heart disease, arthritis, chronic respiratory disorder, chronic inflammatory digestive disease or a gastrointestinal disorder deemed incompatible with the conduct of the study by the investigator (e.g. celiac disease, Crohn's disease, irritable bowel disease, etc.).
- For Women: Non-menopausal woman or menopausal woman with hormone replacement therapy
- Consuming more than 5 cigarettes per day,
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
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 |
|---|---|---|
| VerumAfter randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3). | Dietary supplement | Verum |
| PlaceboAfter randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3). | Dietary supplement | Placebo |
Primary outcome
The change in mental fatigue
Time frame: up to 10 weeks
Mental fatigue is assessed twice on a VAS (Visual Analogue Scale) in the COMPASS test, which is a computerized test assessing cognitive functions. The first VAS is assessed following the cognitive Demand Battery comprising 3 tasks, namely a 3s serial subtraction task, a 7s serial subtraction task and another COMPASS task called Digit vigilance.
3 secondary outcomes
Evolution of global cognitive functioning
Time frame: up to 10 weeks
Evolution of cognitive function
Time frame: up to 10 weeks
The frequency of adverse events
Time frame: up to 10 weeks
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 30 Aug 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum in people with Healthy Subjects, run by Robertet SA at 2 sites 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 12 inclusion and 15 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 change in mental fatigue (time frame: up to 10 weeks). 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 30 Aug 2023.