Clinical trial NCT05472285: Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Bionov
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2022-07-25
Enrollment: 144
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in mental fatigue
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Evolution of global cognitive functioning
timeFrame: up to 10 weeks
measure: Evolution of cognitive function
timeFrame: up to 10 weeks
measure: The frequency of adverse events
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Investigation Unit Biofortis - Paris
city: Saint-Herblain
country: France
facility: Clinical Investigation Unit of Biofortis - SHE
Study officials:
References: