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

NCT05472285 | Completed

• 1 other identifier: 2021-A02122-39
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evolution of global cognitive functioning

  up to 10 weeks

• Evolution of cognitive function

  up to 10 weeks

• The frequency of adverse events

  up to 10 weeks

Study Arms (2)

Verum

ACTIVE COMPARATOR

2 capsules per day during 8 weeks

Dietary Supplement: Verum

Placebo

PLACEBO COMPARATOR

2 capsules per day during 8 weeks

Dietary Supplement: Placebo

Interventions

Verum 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).

Verum

Placebo 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

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bionov: lead
• BioFortis: collaborator

Study Sites (2)

Clinical Investigation Unit Biofortis - Paris

Paris, 75012, France

Location

Clinical Investigation Unit of Biofortis - SHE

Saint-Herblain, 44800, France

Location

MeSH Terms

Interventions

calcium D-pantothenate, L-cysteine drug combination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 25, 2022
• Study Start: May 23, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: August 30, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)