Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06853405

Nutrition-based Interventions to Prevent Cognitive Decline

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Cognition Disorder Cognition Disorders Cognitive Impairment Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Saúde Pública da Universidade do Porto, Porto, Portugal

Loading trial locations.

About this study

The present project is a randomized controlled trial (RCT) to study the feasibility and effectiveness of a 6-month nutrition-based intervention designed to prevent cognitive decline in adults at higher risk of dementia.

Eligible individuals (n=120) recruited at primary health care centers or in the community will be randomized (1:1) into two arms: intervention and control groups.

The intervention group will be invited to participate in nutrition-based sessions of 180-minutes per week, directed by a nutritionist, to improve participants' skills in preparing healthy meals and reduce sedentary behaviours. Participants will also be asked to perform cognitive training at home and to attend individualized clinical nutrition consultations.

The control group will participate in data assessment and will receive a healthy recipes cookbook to thank for their participation. They will also receive an invitation to participate in free healthy cooking workshops, which will be offered upon the completion of the primary data collection endpoint.

Both groups will continue receiving the usual standard care in their healthcare unit.

Participants' assessments will be performed at baseline and will be repeated at the end of intervention (6 months after the beginning of the intervention). A follow-up assessment will be conducted 6 months after the intervention concludes. Adherence outcomes, as well as lifestyle, health and anthropometric data, cognitive performance, subjective memory complaints, anxiety and depression, quality of life and self-reported physical activity will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Nutrition-related lifestyle group sessions

Behavioral

In person lifestyle group sessions of 180-minutes per week, directed by a nutritionist, and comprising:

  • 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.
  • 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.

Primary outcomes

  1. Self-reported adherence to the Mediterranean Diet

    Time frame: Up to 6 months

    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.

  2. Self-reported quality of life

    Time frame: Up to 6 months

    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).

Secondary outcomes

  1. Self-reported memory complaints

    Time frame: Up to 6 months

    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.

  2. Cognitive performance 1

    Time frame: Up to 6 months

    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.

  3. Cognitive performance 2

    Time frame: Up to 6 months

    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.

  4. Anxiety and depression symptoms

    Time frame: Up to 6 months

    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).

  5. Blood Pressure

    Time frame: Up to 6 months

    Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of the intervention.

  6. Body Mass Index

    Time frame: Up to 6 months

    Variation of participant's body mass index between the baseline assessment and the end of the intervention.

  7. Self-reported physical activity

    Time frame: Up to 6 months

    Variation of participants' self-reported physical activity using the short version of the International Physical Activity Questionnaire (IPAQ), between baseline and the end of the intervention. Participants will be classified into 3 levels of physical activity: inactive, minimally active and active.

  8. Health Literacy

    Time frame: Up to 6 months

    Variation of participant's health literacy Portuguese validated version of the NVS - Newest Vital Sign between baseline assessment and the end of the intervention. The NVS includes six questions regarding an ice cream nutrition label. The scores range from 0 to 6 (1 point for each correct answer): a score of 0 - 1 suggests high likelihood of limited literacy; 2 - 3 indicates the possibility of limited literacy; and 4 - 6 almost always indicates adequate literacy.

  9. Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease

    Time frame: Up to 6 months

    Variation of participants' nutrition knowledge about Mediterranean Diet and its health benefits between baseline assessment and the end of the intervention. The nutrition knowledge will be assessed using a 20-item tool, the Mediterranean Diet Nutrition Knowledge Questionnaire (Med-NKQ). In total, the tool score range from 0 to 42, with a higher score indicating greater knowledge.

  10. Adherence to each intervention

    Time frame: Up to 6 months

    Proportion of adherence to each intervention, calculated as the number of sessions attended divided by the total number of sessions implemented.

  11. Dropout

    Time frame: Up to 6 months

    Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session divided by the total number of participants who attended at least one session.

  12. Time of follow-up

    Time frame: Up to 6 months

    Number of days between the first and the last session attended by the participant.

  13. Implemented sessions

    Time frame: Up to 6 months

    Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement divided by the total number of sessions planned.

  14. Complete assessment of participants

    Time frame: Up to 12 months

    For each study outcome, proportion of participants with complete information, calculated at baseline and different moments of follow-up, as the number of participants with complete information divided by the total number of participants evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela de Sousa, Master

CONTACT

[email protected]

+351222061820

Sponsors and collaborators

Lead sponsor

Instituto de Saude Publica da Universidade do Porto

Other

Registry information

Official study title

NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline

Acronym: NUTRIMIND

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.