Nutrition-based Interventions to Prevent Cognitive Decline

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorInstituto de Saude Publica da Universidade do Porto

About this trial

This study intends to evaluate the feasibility and the effectiveness of an innovative and integrated nutrition-based intervention addressing key modifiable risk factors for dementia while meeting participants' preferences for nutrition-related sessions. The intervention will include lifestyle group sessions regarding nutrition education and physical activity, individualized cognitive training at home, as well as clinical nutrition consultations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged from 55 to 85 years old;

At least 4 years in the regular school system;

Higher individual risk for dementia defined as a score ≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE).

Disqualifiers

Montreal Cognitive Assessment (MoCA) score lower than the validated cutoff points defined as 2 standard deviations below the normative reference value for the corresponding age and education in the Portuguese population;

Having a medical condition limiting the participation in the intervention (e.g., blindness, amputation…);

Lack of autonomy in daily activities;

Diagnosis of dementia or major incapacity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutrition-related lifestyle group sessions

    Behavioral

    In person lifestyle group sessions of 180-minutes per week, directed by a nutritionist, and comprising: 1. nutrition education session for preparing healthy meals, followed by a period of social interaction while consuming the meals prepared. Participants will be encouraged to apply the healthy cooking techniques covered in each session in their home context. 2. daily activities to reduce physical inactivity (e.g., walking to the supermarket to buy ingredients, playing traditional games, caring for community gardening, among others).

  • Cognitive training

    Behavioral

    Individualized cognitive training performed remotely, at home on their own. The participants will be invited to perform cognitive training exercises at least twice a week using COGWEB®, an online platform for cognitive training. For those unable to use computer devices, similar exercises will be available in paper-and-pencil format.

  • Clinical nutrition consultations

    Behavioral

    A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: NUTRIMINDExperimental treatment 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Self-reported adherence to the Mediterranean Diet

Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern scale (MEDAS), between the baseline assessment and the end of the intervention. This scale varies from 0 (lowest adherence to the Mediterranean diet) to 14 points (highest adherence to the Mediterranean diet). A score ≥ 10 points indicates good adherence to the Mediterranean diet.

Time frame
Up to 6 months
2

Self-reported quality of life

Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline assessment and the end of the intervention. This scale is subdivided into two subscales: a) five multiple choice questions, with five response possibilities, which produce a score that varies from 5 (best score) to 25 points (worst score); b) visual analogic scale, that varies from 0 (worst score) to 100 (best score).

Time frame
Up to 6 months

Secondary outcomes

1

Self-reported memory complaints

Variation of the self-reported memory complaints, assessed using the Subjective Memory Complaints Scale, between the baseline assessment and the end of the intervention. This scale varies from 0 (best score) to 21 points (worst score). Scores \> 3 points indicate the presence of self-reported memory complaints.

Time frame
Up to 6 months
2

Cognitive performance 1

Participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of the intervention. In this scale the worst cognitive performance is equal to 0 and the best cognitive performance is equal to 30 points.

Time frame
Up to 6 months
3

Cognitive performance 2

Variation of participant's cognitive performance assessed using the Portuguese version of Addenbrooke's Cognitive Examination - Revised (ACE-R), between the baseline assessment and the end of the intervention. This brief test evaluates the following cognitive subdomains: attention and orientation, memory, fluency, language and visuospatial. The test is scored from 0 to 100 points (highest possible score). Higher scores will indicate better cognitive performance.

Time frame
Up to 6 months
4

Anxiety and depression symptoms

Variation of the anxiety and depression scores, assessed using the Hospital Anxiety and Depression Scale (HADS), between the baseline assessment and the end of the intervention. This scale varies from 0 (best score) to 21 points (worst score).

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.