HealthyNUTRIMEMONCT02626247
Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
A study testing Vitamin A +Long chain PUFA in people with Healthy, run by Nutrimemo Consortium at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin A +Long chain PUFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Universitary Hospital Center - USR 3413 SANPSY
Bordeaux, 33000
Cedric Valtat, ARC, +33(0)5 57 82 01 82, cedric.valtat@chu-bordeaux.fr
Cecile klochendler, ARC, +33(0)5 57 82 11 59, cecile.klochendler@chu-bordeaux.fr
About this study
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Vitamin A +Long chain PUFA, Placebo
- Keywords
- elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A +Long chain PUFADietary supplement
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
PlaceboOther
3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A + Long chain PUFA | Active comparator | 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. Receives: Dietary Supplement: Vitamin A +Long chain PUFA |
| Placebo | Placebo comparator | The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
Measured: 52 weeks
Secondary outcomes (23)
Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)
Measured: 52 weeks
Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)
Measured: 52 weeks
McNair scale
The McNair and Kahn scale is a subjective scale used to evaluate the memory complaints in front of everyday conditions.
Measured: 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).
Measured: 52 weeks
Montgomery et Asberg Depression Scale
Measured: 52 weeks
COVI anxiety Scale
Measured: 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.
Measured: 52 weeks
Multidimensional Fatigue Inventory (MFI-20)
Measured: 52 weeks
SF36 (Medical Outcome Study, Short-Form 36)
Measured: 52 weeks
blood lipidic profile
Cholesterol g/L and Triglycerides g/L
Measured: 52 weeks
Glycemia
g/L
Measured: 52 weeks
blood hight sensitive C reactive Protein (CRP)
mg/L
Measured: 52 weeks
blood Retinol
µM/L
Measured: 52 weeks
Blood retinol binding protein (RBP)
mg/L
Measured: 52 weeks
Blood transtyretin
g/L
Measured: 52 weeks
salivary cortisol
nmol/L
Measured: 52 weeks
blood free Thyroxine
g/L
Measured: 52 weeks
Blood triiodothyronine
pg/MmL
Measured: 52 weeks
blood Vitamin D 25 OH
nmol/L
Measured: 52 weeks
Fatty acid profile in erythrocyte membranes
% of total fatty acids
Measured: 52 weeks
Nuclear receptor mRNA expression in mononuclear cells
relative expression
Measured: 52 weeks
blood Inflammatory markers
g/L
Measured: 52 weeks
plasma beta amyloide
pg/mL
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startSep 2013
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrimemo Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux, Unither Pharmaceuticals, France, Company Groupe St Hubert France, VAB Nutrition France, ITERG
- Responsible party
- Sponsor
- Investigators
- Véronique PALLET, Professor, Study director, Laboratoire NutriNeuro INRA-Université de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626247
- Sponsor's protocol ID
- 01
- Acronym
- NUTRIMEMO
- Status last verified
- Dec 2015
- First submitted
- 28 Aug 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults
- ClinicalTrials.gov ID
- NCT02626247
- Acronym / sponsor ID
- NUTRIMEMO / 01
- Conditions
- Healthy
- Keywords
- elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nutrimemo ConsortiumUniversity, hospital or other
- Collaborators
- University of Bordeaux, Unither Pharmaceuticals, France, Company Groupe St Hubert France, VAB Nutrition France, ITERG
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A + Long chain PUFA | Active comparator | Dietary Supplement: Vitamin A +Long chain PUFAThe 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. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A +Long chain PUFA3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water. | Dietary supplement | Vitamin A + Long chain PUFA |
| Placebo3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water. | Other | Placebo |
Primary outcome
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)
Time frame: 52 weeks
23 secondary outcomes
Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)
Time frame: 52 weeks
Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)
Time frame: 52 weeks
McNair scale
Time frame: 52 weeks
Change from baseline of the Verbal fluency measured by Isaac verbal fluency test
Time frame: 52 weeks
Montgomery et Asberg Depression Scale
Time frame: 52 weeks
COVI anxiety Scale
Time frame: 52 weeks
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame: 52 weeks
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 52 weeks
SF36 (Medical Outcome Study, Short-Form 36)
Time frame: 52 weeks
blood lipidic profile
Time frame: 52 weeks
Glycemia
Time frame: 52 weeks
blood hight sensitive C reactive Protein (CRP)
Time frame: 52 weeks
blood Retinol
Time frame: 52 weeks
Blood retinol binding protein (RBP)
Time frame: 52 weeks
Blood transtyretin
Time frame: 52 weeks
salivary cortisol
Time frame: 52 weeks
blood free Thyroxine
Time frame: 52 weeks
Blood triiodothyronine
Time frame: 52 weeks
blood Vitamin D 25 OH
Time frame: 52 weeks
Fatty acid profile in erythrocyte membranes
Time frame: 52 weeks
Nuclear receptor mRNA expression in mononuclear cells
Time frame: 52 weeks
blood Inflammatory markers
Time frame: 52 weeks
plasma beta amyloide
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Universitary Hospital Center - USR 3413 SANPSY
Bordeaux, France
Véronique PALLET, Professor study director
Laboratoire NutriNeuro INRA-Université de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A +Long chain PUFA in people with Healthy, run by Nutrimemo Consortium at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.