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

NCT ID: NCT03080675

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-02-26

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.

Conditions

Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Nutritional blend of ingrédients including vitamins and fish oil

Group Type: EXPERIMENTAL

Nutrional blend of ingredients including vitamins and fish oil

Intervention Type: DIETARY_SUPPLEMENT

Control comparator:

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Nutrional blend of ingredients including vitamins and fish oil

Intervention Type: DIETARY_SUPPLEMENT

Control

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno VELLAS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

CHU Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2016-A01006-45, RC31/16/8196

Identifier Type: REGISTRY

Identifier Source: secondary_id

16.13.NRC

Identifier Type: -

Identifier Source: org_study_id