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

Nutrimemo Consortium

Status: Unknown

Conditions: Healthy

Treatments: Other: Placebo; Dietary Supplement: Vitamin A +Long chain PUFA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02626247

01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 estimated patients

Sex: All

Ages: 60 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Vitamin A + Long chain PUFA

Active Comparator group

Description:

The test product is a food supplement containing Vitamin A + Long chain Poly Unsaturated Fatty Acids (PUFA). It is presented as a hard shell capsule containing lipophylic nutrients.

Treatment:

Dietary Supplement: Vitamin A +Long chain PUFA

Placebo

Placebo Comparator group

Description:

The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.

Treatment:

Other: Placebo