Nutrition-based Interventions to Prevent Cognitive Decline

Not Applicable

Recruiting

• Conditions: Cognitive Dysfunction; Cognition Disorder; Memory Disorders; Cognitive Impairment; Neurocognitive Disorders

• Registration Number: NCT06853405
• Lead Sponsor: Instituto de Saude Publica da Universidade do Porto

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.

Study Timeline

• Study Start: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-10
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported adherence to the Mediterranean Diet	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.
Self-reported quality of life	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 Outcome Measures

Name	Time	Method
Self-reported memory complaints	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.
Cognitive performance 1	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.
Cognitive performance 2	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.
Anxiety and depression symptoms	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).
Blood Pressure	Up to 6 months	Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of the intervention.
Body Mass Index	Up to 6 months	Variation of participant's body mass index between the baseline assessment and the end of the intervention.
Self-reported physical activity	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.
Health Literacy	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.
Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease	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.
Adherence to each intervention	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.
Dropout	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.
Time of follow-up	Up to 6 months	Number of days between the first and the last session attended by the participant.
Implemented sessions	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.
Complete assessment of participants	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.

Trial Locations

Locations (2)

Instituto de Saúde Pública da Universidade do Porto; 🇵🇹 Porto, Portugal

Faculty of Nutrition and Food Sciences, University of Porto; 🇵🇹 Porto, Portugal