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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Verum; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Clinical Investigation Unit Biofortis - Paris
  • Saint-Herblain, France, 44800
    • Clinical Investigation Unit of Biofortis - SHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verum; 2 capsules per day during 8 weeks	Dietary supplement: 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).
Placebo Comparator: Placebo; 2 capsules per day during 8 weeks	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bionov
• Collaborators: BioFortis

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A02122-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No