Cognitive FunctionNCT06631027
Dietary Adherence and Cognitive Function in Older Adults
An observational study of Cognitive Function and Mediterranean Diet, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the relationship between adherence to the Mediterranean, DASH, and MIND diets and cognitive function in elderly individuals. Data were collected from 1,027 participants aged 65 and older, using dietary assessment tools and the Standardized Mini Mental Test (SMMT), and were analyzed with… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Cognitive Function, Mediterranean Diet, Dietary Approaches to Stop Hypertension
- How many people
- 1,027 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 1 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Community sample in Ankara, Turkey
Who may be able to join
- 1. Individuals aged 65 years and older.
Who cannot join
- 1. Individuals diagnosed with psychiatric or neurological diseases (e.g., dementia, Alzheimer\'s disease).
- 3. Individuals with alcohol or drug addiction. 4. Illiterate individuals.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06760
About this study
Official title: The Relationship Between Adherence to Mediterranean, DASH and MIND Diets and Cognitive Function in Older Adults
This study aimed to evaluate the relationship between adherence to the Mediterranean, DASH, and MIND diets and cognitive function in elderly individuals. Data were collected from 1,027 participants aged 65 and older, using dietary assessment tools and the Standardized Mini Mental Test (SMMT), and were analyzed with SPSS 26.
Read the detailed description
A total of 1027 elderly individuals aged 65 years and over were included in the study. Demographic questionnaire and Mediterranean diet adherence scale were administered to the individuals. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet was scored and food consumption was recorded for adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. Standardised mini mental test (SMMT) was used to assess mental status. Data were analysed with SPSS 26 software.
- Conditions
- Cognitive Function, Mediterranean Diet, Dietary Approaches to Stop Hypertension, Elderly Population
- Keywords
- Cognitive Function, Mediterranean Diet, Elderly Health, DASH Diet, MIND Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Participants (65 years and older) | This study focuses on a cohort of 1,027 elderly participants aged 65 years and older. The participants were assessed for their adherence to the Mediterranean, DASH, and MIND diets through a demographic questionnaire and dietary adherence scales. Cognitive function was evaluated using the Standardized Mini-Mental Test (SMMT). The study aims to explore the relationship between dietary patterns and cognitive health in this population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function Assessment
The primary outcome measure is the cognitive function of elderly individuals assessed using the Standardized Mini-Mental Test. The total Standardized Mini-Mental Test score is analyzed to evaluate the relationship between dietary adherence and cognitive function.The test is scored according to the answers given to each question and evaluated over 30 points in total. On a 30-point scale, a score of 24 and above indicates normal cognition, while a score below 24 indicates impaired cognitive function.
Measured: Basaline
Secondary outcomes (7)
Sociodemographic characteristics
number and percentage
Measured: basaline
Mediterranean Diet Adherence Scale
Adherence to the Mediterranean Diet will be assessed using the Mediterranean Diet Adherence Scale. Scores will range from 0 to 14, with scores below 7 indicating non-compliance, 7-8 indicating acceptable compliance, and 9 and above indicating strict adherence to the Mediterranean diet.
Measured: Basaline
Compliance with the Dietary Approaches to Stop Hypertension diet
Compliance with the Dietary Approaches to Stop Hypertension diet will be assessed using a 24-hour recall method to evaluate dietary intake. Scores range from 0 to 9, with scores of 4.5 or above indicating compliance with the DASH diet. This assessment will be used to explore the relationship between DASH diet adherence and cognitive function in elderly individuals.
Measured: Basaline
Compliance with the Mediterranean-DASH Intervention for Neurodegenerative Delay diet
Compliance with the Mediterranean-DASH Intervention for Neurodegenerative Delay diet will be assessed by evaluating the frequency and portion sizes of key dietary components, Higher scores indicate greater adherence to the MIND diet. In this study, a median score of 7.5 will be used to categorize participants into two groups: those with a low level of adherence (score ≤7.5) and those with a high level of adherence (score >7.5).
Measured: Basaline
Body Mass Index (BMI)
Kilograms per square meter (kg/m2)
Measured: Basaline
Body weight
Body weight in kg
Measured: Basaline
Height
Height in cm
Measured: Basaline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,027 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Elibol, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631027
- Sponsor's protocol ID
- AYBUELİBOL001
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Adherence to Mediterranean, DASH and MIND Diets and Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT06631027
- Acronym / sponsor ID
- AYBUELİBOL001
- Conditions
- Cognitive Function, Mediterranean Diet, Dietary Approaches to Stop Hypertension, Elderly Population
- Keywords
- Cognitive Function, Mediterranean Diet, Elderly Health, DASH Diet, MIND Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Oct 2024 (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 aimed to evaluate the relationship between adherence to the Mediterranean, DASH, and MIND diets and cognitive function in elderly individuals. Data were collected from 1,027 participants aged 65 and older, using dietary assessment tools and the Standardized Mini Mental Test (SMMT), and were analyzed with SPSS 26.
Detailed description
A total of 1027 elderly individuals aged 65 years and over were included in the study. Demographic questionnaire and Mediterranean diet adherence scale were administered to the individuals. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet was scored and food consumption was recorded for adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. Standardised mini mental test (SMMT) was used to assess mental status. Data were analysed with SPSS 26 software.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Participants (65 years and older) | – | –This study focuses on a cohort of 1,027 elderly participants aged 65 years and older. The participants were assessed for their adherence to the Mediterranean, DASH, and MIND diets through a demographic questionnaire and dietary adherence scales. Cognitive function was evaluated using the Standardized Mini-Mental Test (SMMT). The study aims to explore the relationship between dietary patterns and cognitive health in this population. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community sample in Ankara, Turkey
Key inclusion criteria (1 listed)
- 1. Individuals aged 65 years and older.
Key exclusion criteria (2 listed)
- 1. Individuals diagnosed with psychiatric or neurological diseases (e.g., dementia, Alzheimer\'s disease).
- 3. Individuals with alcohol or drug addiction. 4. Illiterate individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Function Assessment
Time frame: Basaline
The primary outcome measure is the cognitive function of elderly individuals assessed using the Standardized Mini-Mental Test. The total Standardized Mini-Mental Test score is analyzed to evaluate the relationship between dietary adherence and cognitive function.The test is scored according to the answers given to each question and evaluated over 30 points in total. On a 30-point scale, a score of 24 and above indicates normal cognition, while a score below 24 indicates impaired cognitive function.
7 secondary outcomes
Sociodemographic characteristics
Time frame: basaline
Mediterranean Diet Adherence Scale
Time frame: Basaline
Compliance with the Dietary Approaches to Stop Hypertension diet
Time frame: Basaline
Compliance with the Mediterranean-DASH Intervention for Neurodegenerative Delay diet
Time frame: Basaline
Body Mass Index (BMI)
Time frame: Basaline
Body weight
Time frame: Basaline
Height
Time frame: Basaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Function and Mediterranean Diet, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function Assessment (time frame: Basaline). 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 8 Oct 2024.