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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Verum
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum<br>2 capsules per day during 8 weeks | Dietary Supplement: Verum<br>* After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).<br>|
| Placebo Comparator: Placebo<br>2 capsules per day during 8 weeks | Dietary Supplement: Placebo<br>* After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of global cognitive functioning | Assessed with MMSE score | up to 10 weeks | 
| Evolution of cognitive function | Assessed with COMPASS score | 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 | up to 10 weeks |