Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
NCT ID: NCT02626247
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2013-09-30
2016-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vitamin A + Long chain PUFA
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.
Vitamin A +Long chain PUFA
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
Placebo
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Placebo
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
Interventions
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Vitamin A +Long chain PUFA
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
Placebo
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
70 Years
ALL
Yes
Sponsors
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University of Bordeaux
OTHER
Unither Pharmaceuticals, France
INDUSTRY
Company Groupe St Hubert France
UNKNOWN
VAB Nutrition France
UNKNOWN
ITERG
INDUSTRY
Nutrimemo Consortium
OTHER
Responsible Party
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Principal Investigators
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Véronique PALLET, Professor
Role: STUDY_DIRECTOR
Laboratoire NutriNeuro INRA-Université de Bordeaux
Locations
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Universitary Hospital Center - USR 3413 SANPSY
Bordeaux, , France
Countries
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Facility Contacts
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Cedric Valtat, ARC
Role: primary
Cecile klochendler, ARC
Role: backup
Related Links
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website of the laboratory of Nutrition and integrative neurobiology (NutriNeuro)
Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id