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

NCT03080675 | Completed

• 2 other identifiers: 16.13.NRC2016-A01006-45, RC31/16/8196
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Decline

Keywords

Aging population

Outcome Measures

Primary Outcomes (2)

• 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: 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: 1 year] [Safety Issue: No]

Secondary Outcomes (39)

• 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]

• 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]

• 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]

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

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

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

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

Study Arms (2)

Experimental

EXPERIMENTAL

Nutritional blend of ingrédients including vitamins and fish oil

Dietary Supplement: Nutrional blend of ingredients including vitamins and fish oil

Control comparator:

PLACEBO COMPARATOR

control product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.

Dietary Supplement: Control

Interventions

Nutrional blend of ingredients including vitamins and fish oil DIETARY_SUPPLEMENT

Experimental

Control DIETARY_SUPPLEMENT

Control comparator:

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• University Hospital, Toulouse: collaborator

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Bruno VELLAS

  CHU Toulouse, Gérontopôle, Cité de la Santé, 20 Rue du Pont Saint Pierre, 31059 TOULOUSE Cedex 9

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: March 15, 2017
• Study Start: November 1, 2016
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)