An interventional study of Nutrional blend of ingredients including vitamins and fish oil and Control in Cognitive Decline, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Supportive care
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
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 362 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
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.
Nutritional blend of ingrédients including vitamins and fish oil
Dietary Supplement: Nutrional blend of ingredients including vitamins and fish oil
control product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.
Dietary Supplement: Control
Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline
Plasma erythrocyte-omega 3 index
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
Homocysteine levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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.
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months
Number of symbols reported during 90 seconds
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months
Number of words reported during 2 minutes
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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.
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months
Number of correct words reported in 2 minutes
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months
Number of digits recalled for forwards and backward sequences
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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.
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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.
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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.
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months
Brain connectivity
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline
Amyloid load
Time frame: [Time Frame: 1 years] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months
Brain-Derived Neurotrophic Factor (BDNF) plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months
Aβ40 plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months
Aβ42 plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months
Tau protein plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months
Asymmetric dimethylarginine plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months
Homocysteine plasma levels
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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)
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Changes in levels of plasma nutrient levels at 0, 6 and 12 months
e.g.vitamins, minerals, lipids, amino acids, erythrocyte omega-3 index
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Treatment effects in a subgroup population defined by the below described subject characteristic:
Clinical Dementia Rating (CDR) of 0.5 at baseline
Time frame: [Time Frame: 1 year] [Safety Issue: No]
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
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Treatment effects in a subgroup population defined by the below described subject characteristic:
High plasma homocysteine levels (plasma homocysteine ≥ 12 µmol/L) at baseline
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Treatment effects in a subgroup population defined by the below described subject characteristic:
CAIDE (Cardiovascular Risk Factors, Aging and Dementia) risk score at baseline
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Treatment effects in a subgroup population defined by the below described subject characteristic:
Genotype
Time frame: [Time Frame: 1 year] [Safety Issue: No]
Plan to share: No
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Société des Produits Nestlé (SPN)