Clinical trial NCT03080675: Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
Official title: Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Keywords: Aging population
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Toulouse
First posted: 2017-03-15
Enrollment: 362
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 70 years
2. Spontaneous memory complaints
3. Adequate fluency in the local language to understand the inform consent form and complete any other study document
4. Sufficient vision and hearing to complete study protocol procedures based on medical judgement
5. 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)
6. Has general health status that will not interfere with the ability to complete the study
7. Willing and able to participate and to give written consent to comply with study procedures
8. Willing to be informed in case a new clinical pathology is discovered through clinical examinations

Exclusion Criteria:

1. Exhibiting a loss of independence in basic activities of daily living (ADL score \< 4)
2. MMSE score \< 24
3. Dementia as determined by DSM-V criteria
4. Suffering from diseases that are likely to be life-threatening in the short-term
5. 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
6. Food allergy
7. Taking omega-3 dietary supplements containing \>200 mg DHA per day during the last 6 months
8. Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex
9. Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine)
10. 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).
11. 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:
12. Wearing a pace-maker or having metal in the body which is exclusionary for MRI
13. 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.

Primary outcomes:
measure: Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
Secondary outcomes:
measure: Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in frailty syndromes assessed by the Fried Frailty Criteria at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in brain structure assessed by Magnetic Resonance Imaging (MRI) in a subset of the study population at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: 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
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in brain function assessed by Arterial spin label (ASL) perfusion MRI in a subset of the study population at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in brain structure assessed by MRI diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline
timeFrame: [Time Frame: 1 years] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of blood plasma inflammatory markers 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of blood plasma markers of oxidative stress at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Changes in levels of plasma nutrient levels at 0, 6 and 12 months
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Treatment effects in a subgroup population defined by the below described subject characteristic:
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Treatment effects in a subgroup population defined by the below described subject characteristic:
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Treatment effects in a subgroup population defined by the below described subject characteristic:
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Treatment effects in a subgroup population defined by the below described subject characteristic:
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
measure: Treatment effects in a subgroup population defined by the below described subject characteristic:
timeFrame: [Time Frame: 1 year] [Safety Issue: No]
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse, Gérontopôle, Cité de la Santé, 20 Rue du Pont Saint Pierre, 31059 TOULOUSE Cedex 9
name: Bruno VELLAS
role: PRINCIPAL_INVESTIGATOR
References: