Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
NCT03080675, Not applicable, Completed, Société des Produits Nestlé (SPN)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults | ClinicalTrials.gov |
| NCT number | NCT03080675 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 362 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Société des Produits Nestlé (SPN) | ClinicalTrials.gov |
| Conditions | Cognitive Decline | ClinicalTrials.gov |
| Interventions | Nutrional blend of ingredients including vitamins and fish oil, Control | ClinicalTrials.gov |
| First posted | 2017-03-15 | ClinicalTrials.gov |
| Last updated | 2019-05-23 | ClinicalTrials.gov |
Registered outcomes 41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline | [Time Frame: 1 year] [Safety Issue: No] | Plasma erythrocyte-omega 3 index | ClinicalTrials.gov |
| Primary | Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline | [Time Frame: 1 year] [Safety Issue: No] | Homocysteine levels | ClinicalTrials.gov |
| Secondary | Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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) | ClinicalTrials.gov |
| Secondary | Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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) | ClinicalTrials.gov |
| Secondary | Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Orientation score: Subcale of MMSE (see outcome 8); score from 0 to 10. | ClinicalTrials.gov |
| Secondary | Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Number of symbols reported during 90 seconds | ClinicalTrials.gov |
| Secondary | Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Number of words reported during 2 minutes | ClinicalTrials.gov |
| Secondary | Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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. | ClinicalTrials.gov |
| Secondary | Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Time in sec to complete Trail Making Test parts A and B | ClinicalTrials.gov |
| Secondary | Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Number of correct story elements recalled | ClinicalTrials.gov |
| Secondary | Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Number of correct words reported in 2 minutes | ClinicalTrials.gov |
| Secondary | Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Time required to complete each sub-test and interference measure | ClinicalTrials.gov |
| Secondary | Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | Number of digits recalled for forwards and backward sequences | ClinicalTrials.gov |
| Secondary | Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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) | ClinicalTrials.gov |
| Secondary | Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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) | ClinicalTrials.gov |
| Secondary | Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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 | ClinicalTrials.gov |
| Secondary | Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | EQ-5D-5L score: EQ-5D-5L, 5 item questionnaire and a visual analogue scale ranging from 0-100 to describe health status | ClinicalTrials.gov |
| Secondary | Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | GDS score ranging from 0 to 15: 0-9: Normal ; 10-19: Mild depression ; 20-30 : Severe depression. | ClinicalTrials.gov |
| Secondary | Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | 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. | ClinicalTrials.gov |
| Secondary | Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months | [Time Frame: 1 year] [Safety Issue: No] | SPPB score ranging from 0 to 12. Assessment of score's evolution from baseline to 12 months. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)