AzTrials
AzTrials

Cognitive DeclineNCT03080675

Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

A study testing Nutrional blend of ingredients including vitamins and fish oil in people with Cognitive Decline, run by Société des Produits Nestlé (SPN) at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Cognitive Decline
What is being tested?
Nutrional blend of ingredients including vitamins and fish oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
362 participants
Where
1 siteFrance
Study dates
Nov 2016to 26 Feb 2019
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 70 years
  • Spontaneous memory complaints
  • Adequate fluency in the local language to understand the inform consent form and complete any other study document
  • Sufficient vision and hearing to complete study protocol procedures based on medical judgement
  • Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
  • Has general health status that will not interfere with the ability to complete the study
  • Willing and able to participate and to give written consent to comply with study procedures
  • Willing to be informed in case a new clinical pathology is discovered through clinical examinations

Who cannot join

  • Exhibiting a loss of independence in basic activities of daily living (ADL score < 4)
  • MMSE score < 24
  • Dementia as determined by DSM-V criteria
  • Suffering from diseases that are likely to be life-threatening in the short-term
  • History or presence of a severe disease (e.g., cardiovascular, hepatic, renal (e.g., End Stage Renal Disease), gastroenteral, respiratory, endocrine, neurologic, psychiatric, immunologic, or hematologic disease or other conditions) that could, in the opinion of the investigator, interfere with the subjects safety or ability to complete the trial
  • Food allergy
Show all 15Show fewer
  • Taking omega-3 dietary supplements containing >200 mg DHA per day during the last 6 months
  • Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex
  • Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine)
  • Deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited).
  • Having participated in another clinical study in the previous month or is currently participating in another study.
  • Subjects meeting one or more of the following criteria below will not be included in the PET scan and MRI-scan subset groups:
  • Wearing a pace-maker or having metal in the body which is exclusionary for MRI
  • Claustrophobic
  • Subjects who will participate in the PET-scan and MRI-scan subset groups, will be excluded for a 1-year period of any future projects involving investigations using ionizing radiation.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Toulouse

    Toulouse, 31059

Other trials in France

About this study

To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years

Read the detailed description

This multicenter trial will be a placebo-controlled, double-blind, randomized, 2 parallel groups study. The subjects will be randomly allocated to one of two treatment groups (placebo or nutrition product). The duration of the intervention is 1 year.

The total sample size at baseline is 364 subjects, consisting of non-demented adults with subjective memory concerns aged 70+ years.

Being tested
Nutrional blend of ingredients including vitamins and fish oil, Control
Keywords
Aging population
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrional blend of ingredients including vitamins and fish oilDietary supplement

  • ControlDietary supplement

Study groups in NCT03080675
Study groupRoleWhat they receive
ExperimentalExperimentalNutritional blend of ingrédients including vitamins and fish oil
Receives: Dietary Supplement: Nutrional blend of ingredients including vitamins and fish oil
Control comparator:Placebo comparatorcontrol product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.
Receives: Dietary Supplement: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline

    Plasma erythrocyte-omega 3 index

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  2. Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline

    Homocysteine levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

Secondary outcomes (39)

  1. Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months

    The composite score combines the scores of the following neuropsychological tests: FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall), Orientation score (10 items) from MMSE, Number of symbols reported during 90 sec (Digit symbol Substitution test) and the Number of words reported during 2-minutes (Category naming test)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  2. Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months

    FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  3. Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months

    Orientation score: Subcale of MMSE (see outcome 8); score from 0 to 10.

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  4. Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months

    Number of symbols reported during 90 seconds

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  5. Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months

    Number of words reported during 2 minutes

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  6. Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months

    Total score of the MMSE from 0 to 30. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  7. Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months

    Time in sec to complete Trail Making Test parts A and B

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  8. Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months

    Number of correct story elements recalled

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  9. Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months

    Number of correct words reported in 2 minutes

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  10. Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months

    Time required to complete each sub-test and interference measure

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  11. Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months

    Number of digits recalled for forwards and backward sequences

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  12. Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months

    CDR-SOB score ranging from 0 to 18 (0: Normal ; 0.5-4: Questionable cognitive impairment ; 4.5-9: Mild dementia ; 9.5-15.5: Moderate dementia ; 16-18: Severe dementia)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  13. Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months

    Conversion rates to Mild cognitive impairment (MCI) and to dementia (0 = Normal, 0.5= very mild dementia, 1= mild dementia, 2 = moderate dementia, 3= severe dementia)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  14. Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months

    PROMIS score: 33 items noted from 0 to 5 (Min score= 0, Max score =165) not used as diagnosis score but to assess the performance from baseline

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  15. Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months

    EQ-5D-5L score: EQ-5D-5L, 5 item questionnaire and a visual analogue scale ranging from 0-100 to describe health status

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  16. Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months

    GDS score ranging from 0 to 15: 0-9: Normal ; 10-19: Mild depression ; 20-30 : Severe depression.

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  17. Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months

    Change in the presence (yes-no) and severity score (1: mild; 2: moderate; 3: severe) of 12 neuropsychiatric symptoms related to dementia, as well as informant distress score for each of the present symptoms (from 0: 'No distress' to 5: 'Extreme distress') measured at 0 and 12 months.

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  18. Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months

    SPPB score ranging from 0 to 12. Assessment of score's evolution from baseline to 12 months.

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  19. Changes in frailty syndromes assessed by the Fried Frailty Criteria at 0 and 12 months

    Grip strength, timed walking, involuntary weight loss, fatigue and physical activity (categories: robust, pre-frail, frail)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  20. Changes in brain structure assessed by Magnetic Resonance Imaging (MRI) in a subset of the study population at 0 and 12 months

    Regional tissue volume, Regional tissue thickness, Regional surface area, Intracranial volume (total, regional), Total brain volume, Regional volume (eg hippocampus)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  21. Changes in brain structure assessed by fluid-attenuated inversion recovery (FLAIR) MRI and diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months

    Total white matter lesion volume

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  22. Changes in brain function assessed by Arterial spin label (ASL) perfusion MRI in a subset of the study population at 0 and 12 months

    Cerebral blood flow

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  23. Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months

    Brain connectivity

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  24. Changes in brain structure assessed by MRI diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months

    White matter integrity

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  25. Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline

    Amyloid load

    Measured: [Time Frame: 1 years] [Safety Issue: No]

  26. Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months

    Brain-Derived Neurotrophic Factor (BDNF) plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  27. Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months

    Aβ40 plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  28. Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months

    Aβ42 plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  29. Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months

    Tau protein plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  30. Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months

    Asymmetric dimethylarginine plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  31. Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months

    Homocysteine plasma levels

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  32. Changes in levels of blood plasma inflammatory markers 0, 6 and 12 months

    Inflammatory markers (sCAMs, E-Selectin, TNF-alpha, IL1, IL6, IL10, CRP, neopterin)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  33. Changes in levels of blood plasma markers of oxidative stress at 0, 6 and 12 months

    Markers of oxidative stress (Oxidized Low-density lipoprotein (oxLDL), F2-isoprostane)

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  34. Changes in levels of plasma nutrient levels at 0, 6 and 12 months

    e.g.vitamins, minerals, lipids, amino acids, erythrocyte omega-3 index

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  35. Treatment effects in a subgroup population defined by the below described subject characteristic:

    Clinical Dementia Rating (CDR) of 0.5 at baseline

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  36. Treatment effects in a subgroup population defined by the below described subject characteristic:

    Low DHA status (erythrocyte omega 3 index in the lower quartile) at baseline

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  37. Treatment effects in a subgroup population defined by the below described subject characteristic:

    High plasma homocysteine levels (plasma homocysteine ≥ 12 µmol/L) at baseline

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  38. Treatment effects in a subgroup population defined by the below described subject characteristic:

    CAIDE (Cardiovascular Risk Factors, Aging and Dementia) risk score at baseline

    Measured: [Time Frame: 1 year] [Safety Issue: No]

  39. Treatment effects in a subgroup population defined by the below described subject characteristic:

    Genotype

    Measured: [Time Frame: 1 year] [Safety Issue: No]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study startNov 2016
  3. Primary completion26 Feb 2019
  4. Study completion26 Feb 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080675
Sponsor's protocol ID
16.13.NRC
Other IDs
2016-A01006-45, RC31/16/8196
Status last verified
May 2019
First submitted
18 Oct 2016
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutrional blend of ingredients including vitamins and fish oil in people with Cognitive Decline, run by Société des Produits Nestlé (SPN) 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 23 May 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline (time frame: [Time Frame: 1 year] [Safety Issue: No]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080675.

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 23 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in