Nutrition-based Interventions to Prevent Cognitive Decline

NCT06853405 | Recruiting

• 1 other identifier: NUTRIMIND_2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 cognitive training at home, as well as clinical nutrition consultations.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 6 months

• 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).

  Up to 6 months

Secondary Outcomes (14)

• Self-reported memory complaints

  Up to 6 months

• Cognitive performance 1

  Up to 6 months

• Cognitive performance 2

  Up to 6 months

• Anxiety and depression symptoms

  Up to 6 months

• Blood Pressure

  Up to 6 months

Study Arms (2)

NUTRIMIND

EXPERIMENTAL

The NUTRIMIND arm will be invited to receive a multidomain nutrition-based intervention to prevent cognitive decline, including lifestyle group sessions of nutrition education, daily activities to reduce physical inactivity, as well as individualized cognitive training and individualized clinical nutrition consultations. They will continue receiving the usual standard care in their healthcare unit.

Behavioral: Nutrition-related lifestyle group sessions; Behavioral: Cognitive training; Behavioral: Clinical nutrition consultations

Control

NO INTERVENTION

The control arm will receive a healthy recipe cookbook and will also be invited to attend free healthy cooking workshops after the data collection phase concludes. And will continue receiving the usual standard care in their healthcare unit.

Interventions

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).

NUTRIMIND

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.

NUTRIMIND

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.

NUTRIMIND

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Saude Publica da Universidade do Porto: lead

Study Sites (2)

Instituto de Saúde Pública da Universidade do Porto

Porto, Portugal, 4000-600, Portugal

RECRUITING

Faculty of Nutrition and Food Sciences, University of Porto

Porto, 4150-180, Portugal

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Memory Disorders; Neurocognitive Disorders; Dementia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Daniela de Sousa, Master

CONTACT

+351222061820; daniela.sousa@ispup.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will generate the randomization sequence, will inform the participants of their allocation group and will be responsible for the intervention's sessions. The assessors will not know each participants' allocation group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 3, 2025
• Study Start: January 27, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

PT (2)