Clinical trial NCT02626247: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
Official title: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: elderly
Lead sponsor: Nutrimemo Consortium
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
name: Unither Pharmaceuticals, France
name: Company Groupe St Hubert France
name: VAB Nutrition France
name: ITERG
First posted: 2015-12-10
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)
timeFrame: 52 weeks
measure: Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)
timeFrame: 52 weeks
measure: McNair scale
timeFrame: 52 weeks
measure: Change from baseline of the Verbal fluency measured by Isaac verbal fluency test
timeFrame: 52 weeks
measure: Montgomery et Asberg Depression Scale
timeFrame: 52 weeks
measure: COVI anxiety Scale
timeFrame: 52 weeks
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: 52 weeks
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 52 weeks
measure: SF36 (Medical Outcome Study, Short-Form 36)
timeFrame: 52 weeks
measure: blood lipidic profile
timeFrame: 52 weeks
measure: Glycemia
timeFrame: 52 weeks
measure: blood hight sensitive C reactive Protein (CRP)
timeFrame: 52 weeks
measure: blood Retinol
timeFrame: 52 weeks
measure: Blood retinol binding protein (RBP)
timeFrame: 52 weeks
measure: Blood transtyretin
timeFrame: 52 weeks
measure: salivary cortisol
timeFrame: 52 weeks
measure: blood free Thyroxine
timeFrame: 52 weeks
measure: Blood triiodothyronine
timeFrame: 52 weeks
measure: blood Vitamin D 25 OH
timeFrame: 52 weeks
measure: Fatty acid profile in erythrocyte membranes
timeFrame: 52 weeks
measure: Nuclear receptor mRNA expression in mononuclear cells
timeFrame: 52 weeks
measure: blood Inflammatory markers
timeFrame: 52 weeks
measure: plasma beta amyloide
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Universitary Hospital Center - USR 3413 SANPSY
Study officials:
affiliation: Laboratoire NutriNeuro INRA-Université de Bordeaux
name: Véronique PALLET, Professor
role: STUDY_DIRECTOR
References: