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Trial record 1 of 1 for:    nutrimemo
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Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults (NUTRIMEMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626247
Recruitment Status : Unknown
Verified December 2015 by Nutrimemo Consortium.
Recruitment status was:  Recruiting
First Posted : December 10, 2015
Last Update Posted : December 11, 2015
Sponsor:
Collaborators:
Laboratory of Nutrition And Integrative Neurbiology INRA - Bordeaux University
Unither Pharmaceuticals, France
Company Groupe St Hubert France
VAB Nutrition France
ITERG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Vitamin A +Long chain PUFA Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
Study Start Date : September 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Vitamin A

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Vitamin A +Long chain PUFA
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.

Placebo Comparator: Placebo
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Other: Placebo
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.




Primary Outcome Measures :
  1. Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP) [ Time Frame: 52 weeks ]
  2. Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS) [ Time Frame: 52 weeks ]
  3. McNair scale [ Time Frame: 52 weeks ]
    The McNair and Kahn scale is a subjective scale used to evaluate the memory complaints in front of everyday conditions.

  4. Change from baseline of the Verbal fluency measured by Isaac verbal fluency test [ Time Frame: 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).

  5. Montgomery et Asberg Depression Scale [ Time Frame: 52 weeks ]
  6. COVI anxiety Scale [ Time Frame: 52 weeks ]
  7. Change From Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: 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.

  8. Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 52 weeks ]
  9. SF36 (Medical Outcome Study, Short-Form 36) [ Time Frame: 52 weeks ]
  10. blood lipidic profile [ Time Frame: 52 weeks ]
    Cholesterol g/L and Triglycerides g/L

  11. Glycemia [ Time Frame: 52 weeks ]
    g/L

  12. blood hight sensitive C reactive Protein (CRP) [ Time Frame: 52 weeks ]
    mg/L

  13. blood Retinol [ Time Frame: 52 weeks ]
    µM/L

  14. Blood retinol binding protein (RBP) [ Time Frame: 52 weeks ]
    mg/L

  15. Blood transtyretin [ Time Frame: 52 weeks ]
    g/L

  16. salivary cortisol [ Time Frame: 52 weeks ]
    nmol/L

  17. blood free Thyroxine [ Time Frame: 52 weeks ]
    g/L

  18. Blood triiodothyronine [ Time Frame: 52 weeks ]
    pg/MmL

  19. blood Vitamin D 25 OH [ Time Frame: 52 weeks ]
    nmol/L

  20. Fatty acid profile in erythrocyte membranes [ Time Frame: 52 weeks ]
    % of total fatty acids

  21. Nuclear receptor mRNA expression in mononuclear cells [ Time Frame: 52 weeks ]
    relative expression

  22. blood Inflammatory markers [ Time Frame: 52 weeks ]
    g/L

  23. plasma beta amyloide [ Time Frame: 52 weeks ]
    pg/mL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626247


Locations
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France
Universitary Hospital Center - USR 3413 SANPSY Recruiting
Bordeaux, France, 33000
Contact: Cedric Valtat, ARC    +33(0)5 57 82 01 82    cedric.valtat@chu-bordeaux.fr   
Contact: Cecile klochendler, ARC    +33(0)5 57 82 11 59    cecile.klochendler@chu-bordeaux.fr   
Principal Investigator: Pierre PHILIP, MD         
Sub-Investigator: Véronique PALLET, PhD         
Sub-Investigator: Andréa COMENDUCCI         
Sponsors and Collaborators
Nutrimemo Consortium
Laboratory of Nutrition And Integrative Neurbiology INRA - Bordeaux University
Unither Pharmaceuticals, France
Company Groupe St Hubert France
VAB Nutrition France
ITERG
Investigators
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Study Director: Véronique PALLET, Professor Laboratoire NutriNeuro INRA-Université de Bordeaux

Additional Information:
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Responsible Party: Nutrimemo Consortium
ClinicalTrials.gov Identifier: NCT02626247    
Other Study ID Numbers: 01
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Nutrimemo Consortium:
elderly
Additional relevant MeSH terms:
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Vitamins
Vitamin A
Retinol palmitate
Nutrients
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents