Nutrition-based Interventions to Prevent Cognitive Decline

NCT ID: NCT06853405

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Cognitive Dysfunction Cognition Disorder Memory Disorders Cognitive Impairment Neurocognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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NUTRIMIND

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.

Group Type EXPERIMENTAL

Nutrition-related lifestyle group sessions

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Saude Publica da Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto de Saúde Pública da Universidade do Porto

Porto, Portugal, Portugal

Site Status RECRUITING

Faculty of Nutrition and Food Sciences, University of Porto

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Daniela de Sousa, Master

Role: CONTACT

+351222061820

Facility Contacts

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Daniela de Sousa, Master

Role: primary

+351222061820

Daniela M de Sousa, Master

Role: primary

+351 928164872

Other Identifiers

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NUTRIMIND_2024

Identifier Type: -

Identifier Source: org_study_id

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