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

NCT ID: NCT05472285

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-05-23

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Verum

2 capsules per day during 8 weeks

Group Type: ACTIVE_COMPARATOR

Verum

Intervention Type: 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

2 capsules per day during 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

Verum

After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Bionov

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Investigation Unit Biofortis - Paris

Paris, , France

Clinical Investigation Unit of Biofortis - SHE

Saint-Herblain, , France

Countries

France

Other Identifiers

2021-A02122-39

Identifier Type: -

Identifier Source: org_study_id