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

Bionov

Status: Completed

Conditions: Healthy Subjects

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Verum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05472285

2021-A02122-39

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 55 to 70 years old

Volunteers: 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Verum

Active Comparator group

Description:

2 capsules per day during 8 weeks

Treatment:

Dietary Supplement: Verum

Placebo

Placebo Comparator group

Description:

2 capsules per day during 8 weeks

Treatment:

Dietary Supplement: Placebo