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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Vitamin A +Long chain PUFA; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Universitary Hospital Center - USR 3413 SANPSY
    • Contact: Cedric Valtat, ARC; Phone Number: +33(0)5 57 82 01 82; Email: cedric.valtat@chu-bordeaux.fr
    • Contact: Cecile klochendler, ARC; Phone Number: +33(0)5 57 82 11 59; Email: cecile.klochendler@chu-bordeaux.fr
    • Principal Investigator: Pierre PHILIP, MD
    • Sub-Investigator: Véronique PALLET, PhD
    • Sub-Investigator: Andréa COMENDUCCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
McNair scale	The McNair and Kahn scale is a subjective scale used to evaluate the memory complaints in front of everyday conditions.	52 weeks
Change from baseline of the Verbal fluency measured by Isaac verbal fluency test	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).	52 weeks
Montgomery et Asberg Depression Scale		52 weeks
COVI anxiety Scale		52 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)	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.	52 weeks
Multidimensional Fatigue Inventory (MFI-20)		52 weeks
SF36 (Medical Outcome Study, Short-Form 36)		52 weeks
blood lipidic profile	Cholesterol g/L and Triglycerides g/L	52 weeks
Glycemia	g/L	52 weeks
blood hight sensitive C reactive Protein (CRP)	mg/L	52 weeks
blood Retinol	µM/L	52 weeks
Blood retinol binding protein (RBP)	mg/L	52 weeks
Blood transtyretin	g/L	52 weeks
salivary cortisol	nmol/L	52 weeks
blood free Thyroxine	g/L	52 weeks
Blood triiodothyronine	pg/MmL	52 weeks
blood Vitamin D 25 OH	nmol/L	52 weeks
Fatty acid profile in erythrocyte membranes	% of total fatty acids	52 weeks
Nuclear receptor mRNA expression in mononuclear cells	relative expression	52 weeks
blood Inflammatory markers	g/L	52 weeks
plasma beta amyloide	pg/mL	52 weeks

Collaborators and Investigators

• Sponsor: Nutrimemo Consortium
• Collaborators: ITERG; Unither Pharmaceuticals, France; Laboratory of Nutrition And Integrative Neurbiology INRA - Bordeaux University; Company Groupe St Hubert France; VAB Nutrition France
• Investigators: Study Director: Véronique PALLET, Professor, Laboratoire NutriNeuro INRA-Université de Bordeaux

Publications and helpful links

Helpful Links

• website of the laboratory of Nutrition and integrative neurobiology (NutriNeuro)

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: elderly
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 01 (Miami VAHS)