Cognitive DysfunctionNUTRIMINDNCT06853405
Nutrition-based Interventions to Prevent Cognitive Decline
A study testing Nutrition-related lifestyle group sessions, Cognitive training and Clinical nutrition consultations in people with Cognitive Dysfunction and Cognition Disorder, run by Instituto de Saude Publica da Universidade do Porto at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cognitive Dysfunction, Cognition Disorder, Memory Disorders
- What is being tested?
- Nutrition-related lifestyle group sessions, Cognitive training and Clinical nutrition consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesPortugal
- Study dates
- 27 Jan 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 2 recruiting
- Recruiting
Instituto de Saúde Pública da Universidade do Porto
Porto, Portugal, 4000-600
Daniela de Sousa, Master, +351222061820, daniela.sousa@ispup.up.pt
Patrícia Padrão, PhD
- Recruiting
Faculty of Nutrition and Food Sciences, University of Porto
Porto, 4150-180
Daniela M de Sousa, Master, +351 928164872, daniela.sousa@ispup.up.pt
About this study
Official title: NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline
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.
Read the 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
- Being tested
- Nutrition-related lifestyle group sessions, Cognitive training, Clinical nutrition consultations
- Keywords
- Healthy Aging, Dementia, Cognitive Dysfunction, Diet, Food and Nutrition, Diet, Mediterranean, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders, Neurocognitive Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition-related lifestyle group sessionsBehavioural
In person lifestyle group sessions of 180-minutes per week, directed by a nutritionist, and comprising:
- 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.
- 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 trainingBehavioural
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 consultationsBehavioural
A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 6 months
Secondary outcomes (14)
Self-reported memory complaints
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.
Measured: Up to 6 months
Cognitive performance 1
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.
Measured: Up to 6 months
Cognitive performance 2
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.
Measured: Up to 6 months
Anxiety and depression symptoms
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).
Measured: Up to 6 months
Blood Pressure
Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of the intervention.
Measured: Up to 6 months
Body Mass Index
Variation of participant's body mass index between the baseline assessment and the end of the intervention.
Measured: Up to 6 months
Self-reported physical activity
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.
Measured: Up to 6 months
Health Literacy
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.
Measured: Up to 6 months
Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease
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.
Measured: Up to 6 months
Adherence to each intervention
Proportion of adherence to each intervention, calculated as the number of sessions attended divided by the total number of sessions implemented.
Measured: Up to 6 months
Dropout
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.
Measured: Up to 6 months
Time of follow-up
Number of days between the first and the last session attended by the participant.
Measured: Up to 6 months
Implemented sessions
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.
Measured: Up to 6 months
Complete assessment of participants
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Jan 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853405
- Sponsor's protocol ID
- NUTRIMIND_2024
- Acronym
- NUTRIMIND
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline
- ClinicalTrials.gov ID
- NCT06853405
- Acronym / sponsor ID
- NUTRIMIND / NUTRIMIND_2024
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NUTRIMIND | Experimental | Behavioral: Nutrition-related lifestyle group sessions, Behavioral: Cognitive training, Behavioral: Clinical nutrition consultationsThe 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. |
| 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition-related lifestyle group sessionsIn 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). | Behavioural | NUTRIMIND |
| Cognitive trainingIndividualized 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. | Behavioural | NUTRIMIND |
| Clinical nutrition consultationsA registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period. | Behavioural | NUTRIMIND |
Primary outcome
Self-reported adherence to the Mediterranean Diet
Time frame: 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
Time frame: 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).
14 secondary outcomes
Self-reported memory complaints
Time frame: Up to 6 months
Cognitive performance 1
Time frame: Up to 6 months
Cognitive performance 2
Time frame: Up to 6 months
Anxiety and depression symptoms
Time frame: Up to 6 months
Blood Pressure
Time frame: Up to 6 months
Body Mass Index
Time frame: Up to 6 months
Self-reported physical activity
Time frame: Up to 6 months
Health Literacy
Time frame: Up to 6 months
Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease
Time frame: Up to 6 months
Adherence to each intervention
Time frame: Up to 6 months
Dropout
Time frame: Up to 6 months
Time of follow-up
Time frame: Up to 6 months
Implemented sessions
Time frame: Up to 6 months
Complete assessment of participants
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition-related lifestyle group sessions, Cognitive training and Clinical nutrition consultations in people with Cognitive Dysfunction and Cognition Disorder, run by Instituto de Saude Publica da Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela de Sousa, Master (+351222061820, daniela.sousa@ispup.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported adherence to the Mediterranean Diet (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.