Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
时间窗: 52 weeks
次要结局
- McNair scale(52 weeks)
- blood Vitamin D 25 OH(52 weeks)
- blood Inflammatory markers(52 weeks)
- COVI anxiety Scale(52 weeks)
- SF36 (Medical Outcome Study, Short-Form 36)(52 weeks)
- blood Retinol(52 weeks)
- Blood retinol binding protein (RBP)(52 weeks)
- Blood transtyretin(52 weeks)
- 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 free Thyroxine(52 weeks)
- Blood triiodothyronine(52 weeks)
- Nuclear receptor mRNA expression in mononuclear cells(52 weeks)
- Montgomery et Asberg Depression Scale(52 weeks)
- Change From Baseline in Mini-Mental State Examination (MMSE)(52 weeks)
- Multidimensional Fatigue Inventory (MFI-20)(52 weeks)
- blood lipidic profile(52 weeks)
- blood hight sensitive C reactive Protein (CRP)(52 weeks)
- Change from baseline of the Verbal fluency measured by Isaac verbal fluency test(52 weeks)
- Glycemia(52 weeks)
- salivary cortisol(52 weeks)
- Fatty acid profile in erythrocyte membranes(52 weeks)
- plasma beta amyloide(52 weeks)