Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults

Not Applicable

• Conditions: Healthy

• Registration Number: NCT02626247
• Lead Sponsor: Nutrimemo Consortium

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-08-28
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11
• Primary Completion: 2016-04
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Independent subjects

• Living at home non diagnosed as Alzheimer

• Body Mass Index (BMI) 20-30 kg/m2 (limits included);

• 26 < MMSE score ≤ 29

• Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) - sub-scores complying with the following:

  • Immediate recall score < 29;
  • Delayed recall score < 16;

Exclusion Criteria

• Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);
• Subject consuming food supplements likely to have an effect on memory or within less than 6 months;
• Subject consuming high level of Vitamin A and/or Long chain n-3 PUFA evaluated by a food frequency questionnaire,
• Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, ...) self-declared at V0;
• Alcohol consumption > 4 glasses/day
• Diabetes;
• Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included;
• Unbalanced thyroid disease;
• Anti-depressant treatment stopped since less than 3 months or still ongoing;
• Personal history of schizophrenia or other psychiatric disorders;
• Ongoing neuroleptic treatment;
• Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration);
• Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing;
• General anesthesia in the last 6 months or planned in the next 6 months;
• Documented food allergy(ies), namely to one of the components of the study product;
• Psychological or linguistic incapability to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)	52 weeks

Secondary Outcome Measures

Name	Time	Method
McNair scale	52 weeks	The McNair and Kahn scale is a subjective scale used to evaluate the memory complaints in front of everyday conditions.
blood Vitamin D 25 OH	52 weeks	nmol/L
blood Inflammatory markers	52 weeks	g/L
COVI anxiety Scale	52 weeks
SF36 (Medical Outcome Study, Short-Form 36)	52 weeks
blood Retinol	52 weeks	µM/L
Blood retinol binding protein (RBP)	52 weeks	mg/L
Blood transtyretin	52 weeks	g/L
Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)	52 weeks
Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)	52 weeks
Blood triiodothyronine	52 weeks	pg/MmL
Nuclear receptor mRNA expression in mononuclear cells	52 weeks	relative expression
Montgomery et Asberg Depression Scale	52 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)	52 weeks	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.
Multidimensional Fatigue Inventory (MFI-20)	52 weeks
blood lipidic profile	52 weeks	Cholesterol g/L and Triglycerides g/L
blood hight sensitive C reactive Protein (CRP)	52 weeks	mg/L
Change from baseline of the Verbal fluency measured by Isaac verbal fluency test	52 weeks	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).
salivary cortisol	52 weeks	nmol/L
Fatty acid profile in erythrocyte membranes	52 weeks	% of total fatty acids
plasma beta amyloide	52 weeks	pg/mL
blood free Thyroxine	52 weeks	g/L
Glycemia	52 weeks	g/L

Trial Locations

Locations (1)

Universitary Hospital Center - USR 3413 SANPSY; 🇫🇷 Bordeaux, France