Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors

NCT05472285 — Not applicable, Completed, 144 participants, Robertet SA

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors: a Randomized Double-blind Study Versus Placebo

RegistryNCT05472285, acronym BioMind
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, other
Enrollment144 (Actual)
SponsorRobertet SA (Industry); collaborators: BioFortis
ConditionsHealthy Subjects
InterventionsVerum, Placebo (Dietary supplement)
Datesstart 2022-05-23, primary completion 2023-05-23, completion 2023-05-23, first posted 2022-07-25, last updated 2023-08-30
Locations2 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Subjects All trials of Verum All trials of Placebo

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
VerumActive comparatorDietary Supplement: Verum2 capsules per day during 8 weeks
PlaceboPlacebo comparatorDietary Supplement: Placebo2 capsules per day during 8 weeks
  • Verum (Dietary 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).
  • Placebo (Dietary 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).

+Outcome measures

Primary outcomes

  • The change in mental fatigue [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.

Secondary outcomes

  • Evolution of global cognitive functioning [up to 10 weeks]: Assessed with MMSE score
  • Evolution of cognitive function [up to 10 weeks]: Assessed with COMPASS score
  • The frequency of adverse events [up to 10 weeks]: 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

+Eligibility

Sex: All, ages: 55 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* 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,
* 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.

Exclusion Criteria:

* 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.
* 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.

+Locations (2)

FacilityCityCountryStatus
Clinical Investigation Unit Biofortis - ParisParisFrance
Clinical Investigation Unit of Biofortis - SHESaint-HerblainFrance