NCT06853405

Nutrition-based Interventions to Prevent Cognitive Decline

NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Instituto de Saude Publica da Universidade do Porto · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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 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 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.

Conditions

• Cognitive Dysfunction
• Cognition Disorder
• Memory Disorders
• Cognitive Impairment
• Neurocognitive Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Nutrition-related lifestyle group sessions	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).
BEHAVIORAL	Cognitive training	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.
BEHAVIORAL	Clinical nutrition consultations	A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2025-03-03
• Last updated: 2025-12-05

Locations

2 sites across 1 country: Portugal