Clinical trial NCT06853405: Nutrition-based Interventions to Prevent Cognitive Decline
Official title: NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Cognition Disorder
Memory Disorders
Cognitive Impairment
Neurocognitive Disorders
Keywords: Healthy Aging
Dementia
Cognitive Dysfunction
Diet, Food and Nutrition
Diet, Mediterranean
Randomized Controlled Trial
Lead sponsor: Instituto de Saude Publica da Universidade do Porto
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this parallel randomized trial, eligible participants after giving their consent will be randomly allocated (1:1) into 2-arms using a sequence generated in WinPepi® software: the intervention and the control groups. Once the randomization is completed, the principal investigator will inform the participants of their group allocation. Both groups will be assessed concurrently, and participants in one group do not cross over into the other group during the study.
Primary purpose: PREVENTION

Brief summary: 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 nutrition-based cognitive training at home, as well as clinical nutrition consultations.

Detailed description: 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 nutrition-based 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 data collection.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported adherence to the Mediterranean Diet
timeFrame: Up to 6 months
measure: Self-reported quality of life
timeFrame: Up to 6 months
Secondary outcomes:
measure: Self-reported memory complaints
timeFrame: Up to 6 months
measure: Cognitive performance 1
timeFrame: Up to 6 months
measure: Cognitive performance 2
timeFrame: Up to 6 months
measure: Anxiety and depression symptoms
timeFrame: Up to 6 months
measure: Blood Pressure
timeFrame: Up to 6 months
measure: Body Mass Index
timeFrame: Up to 6 months
measure: Self-reported physical activity
timeFrame: Up to 6 months
measure: Health Literacy
timeFrame: Up to 6 months
measure: Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease
timeFrame: Up to 6 months
measure: Adherence to each intervention
timeFrame: Up to 6 months
measure: Dropout
timeFrame: Up to 6 months
measure: Time of follow-up
timeFrame: Up to 6 months
measure: Implemented sessions
timeFrame: Up to 6 months
measure: Complete assessment of participants
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto de Saúde Pública da Universidade do Porto
city: Porto
country: Portugal
facility: Faculty of Nutrition and Food Sciences, University of Porto
Study officials:
References: