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

Nestlé

Status

Completed

Conditions

Cognitive Decline

Treatments

Dietary Supplement: Control

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03080675

16.13.NRC

2016-A01006-45, RC31/16/8196 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

362 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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:
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.