Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms) placebo-controlled design.
This project aims to investigate the effects of 12 months supplementation with a mix of Vitamin A + Long chain n-3 PUFA vs placebo to consume daily on human cognitive functions. Food supplement and placebo will be provided as capsules matched for appearance. The study will be conducted as a randomized, double-blind, parallel-groups (2 arms) placebo-controlled. Two groups, each of 180 volunteers, are recruited. One group of volunteers will consume the Vitamin A + Long chain n-3 PUFA mix while the other one will consume the placebo product. Each volunteer will be seen for 5 visits at the investigational site. Baseline and the last follow-up visit will include cognitive assessment with the CANTAB battery. CANTAB tests will cover several aspects of memory: visio-spatial learning and episodic memory, visio-spatial working memory, frontal executive functions, but also word-based semantic memory. Moreover, psychological and mood components will be evaluated (mnesic complaint, depression, fatigue). Physical activity will also be recorded. Finally, biological parameters will be assessed (lipid profile, glycemia, CRP, thyroid stimulating hormone, transthyretin, plasma level of vitamin A and D as well as retinol binding protein and lipidic profile).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
Universitary Hospital Center - USR 3413 SANPSY
Bordeaux, France
RECRUITINGChange From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
Time frame: 52 weeks
Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)
Time frame: 52 weeks
Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)
Time frame: 52 weeks
McNair scale
The McNair and Kahn scale is a subjective scale used to evaluate the memory complaints in front of everyday conditions.
Time frame: 52 weeks
Change from baseline of the Verbal fluency measured by Isaac verbal fluency test
Isaac verbal fluency test is a test for semantic memory and verbal fluency. The test consists to ask the patient to name in 15 seconds the most possible words around 4 semantic categories: colors, animals, fruits, cities (10 responses by category and score/40).
Time frame: 52 weeks
Montgomery et Asberg Depression Scale
Time frame: 52 weeks
COVI anxiety Scale
Time frame: 52 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)
The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.
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Time frame: 52 weeks
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 52 weeks
SF36 (Medical Outcome Study, Short-Form 36)
Time frame: 52 weeks
blood lipidic profile
Cholesterol g/L and Triglycerides g/L
Time frame: 52 weeks
Glycemia
g/L
Time frame: 52 weeks
blood hight sensitive C reactive Protein (CRP)
mg/L
Time frame: 52 weeks
blood Retinol
µM/L
Time frame: 52 weeks
Blood retinol binding protein (RBP)
mg/L
Time frame: 52 weeks
Blood transtyretin
g/L
Time frame: 52 weeks
salivary cortisol
nmol/L
Time frame: 52 weeks
blood free Thyroxine
g/L
Time frame: 52 weeks
Blood triiodothyronine
pg/MmL
Time frame: 52 weeks
blood Vitamin D 25 OH
nmol/L
Time frame: 52 weeks
Fatty acid profile in erythrocyte membranes
% of total fatty acids
Time frame: 52 weeks
Nuclear receptor mRNA expression in mononuclear cells
relative expression
Time frame: 52 weeks
blood Inflammatory markers
g/L
Time frame: 52 weeks
plasma beta amyloide
pg/mL
Time frame: 52 weeks