Alzheimer Disease (AD)NCT07163923
MIND Diet in Relation to Malnutrition and Depression in AD
An observational study of Alzheimer Disease (AD) and Healthy Controls Group - Age and Sex-matched, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the association between depression, malnutrition, and the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet in Alzheimer's disease patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease (AD), Healthy Controls Group - Age and Sex-matched
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Oct 2024
- How long will I take part?
- 4 Months
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study was planned as a case-control study. The study was conducted on healthy individuals with AD who were admitted to Bolu Abant İzzet Baysal University Training and Research Hospital Neurology Outpatient Clinic and volunteered to participate in the study. In the study, according to the 5% significance level (α = 0.05), 80% statistical power (1-β = 0.80) and sample size calculation for two groups (AD and control group), it was determined that at least 30 individuals should be included in each group in order to detect a medium-large effect size (Cohen's d ≈ 0.66). Therefore, 30 AD and 30 healthy individuals (control group) who volunteered to participate in the study were included.
Who may be able to join
- Patients aged over 60 years.
- Diagnosed with Alzheimer's disease (AD) (for AD group)
- Able to communicate with themselves or their companions
- Healthy volunteers without systemic or neurological diseases (for control group)
- Matching criteria: Age, gender, smoking status, and alcohol use
Who cannot join
- Chronic inflammatory diseases
- Schizophrenia
- Bipolar disorder
- Amputations
- Neoplastic disorders
- End-stage liver disease
- End-stage kidney disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University, Faculty of Health Sciences
Bolu
About this study
Official title: The Role of the MIND Diet in Alzheimer's Disease Patients: A Case-Control Study on Malnutrition and Depression
The aim of this study was to examine the association between depression, malnutrition, and the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet in Alzheimer's disease patients. This study included 30 patients with Alzheimer's disease (AD) and 30 healthy controls. A questionnaire form including sociodemographic characteristics was applied to the individuals. In addition, anthropometric measurements, biochemical parameters, nutritional status (Food Frequency Questionnaire (FFQ), Mini Nutritional Assessment-Short Form (MNA-SF), Geriatric Nutritional Risk Index (GNRI) and MIND diet scores) and mental health status (Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI)).
Read the detailed description
Significant progress has been made in understanding the neurobiological basis and treatment approaches for Alzheimer's disease (AD) and depression; however, the biological link between these two disorders has not yet been fully elucidated. A deeper understanding of this relationship could contribute to the development of more effective strategies for the prevention and treatment of both conditions. In this context, lifestyle-based interventions, such as nutrition, which have been shown to support cognitive health, emerge as a potential preventive and therapeutic approach. Therefore, the aim of this study was to examine the relationship between depression, malnutrition, and the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet in individuals with AD.
- Keywords
- Alzheimer disease, Depression, Diet, Malnutrition
- Medical subject headings
- Alzheimer Disease, Depression, Malnutrition
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 |
|---|---|---|
| Alzheimer's Disease Patients | Participants diagnosed with Alzheimer's disease according to established clinical criteria. Evaluated for malnutrition and depression status. No intervention was applied. | |
| Healthy Controls | Age- and sex-matched individuals without Alzheimer's disease. Evaluated for malnutrition and depression status. No intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Form
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.
Measured: 4 months
Body weight (BW)
BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.
Measured: 4 months
Height
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Measured: 4 months
Waist Circumference (WC)
WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.
Measured: 4 months
Hip Circumference (HC)
HC was measured at the widest point of the hips using a flexible measuring tape.
Measured: 4 months
Body Mass Index (BMI)
BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).
Measured: 4 months
Fasting Blood Glucose
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Measured: 4 months
Triglycerides
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
Measured: 4 months
LDL-Cholesterol
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Measured: 4 months
Total Cholesterol
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
Measured: 4 months
Albumin
Serum albumin levels were measured using routine laboratory procedures in outpatient visits.
Measured: 4 months
Vitamin D
Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.
Measured: 4 months
Folic Acid
Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.
Measured: 4 months
Vitamin B12
Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.
Measured: 4 months
Food Frequency Questionnaire
The foods consumed by individuals in the last month were evaluated across seven different groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugar and fats), beverages, and fast food. Participants were asked how often they consumed foods and beverages in these groups; responses were collected using the following options: "every meal," "every day," "5-6 days a week," "3-4 days a week," "1-2 days a week," "once every 15 days," "once a month," and "never." To determine the average daily consumption amounts based on consumption frequency, the following coefficients were used: 3 for "every meal," 1 for "every day," 0.7855 for "5-6 times a week," 0.498 for "3-4 times a week," 0.2145 for "1-2 times a week," 0.067 for "every 15 days," and 0.033 for "once a month."
Measured: 4 months
MIND diet compliance score
It includes a total of 15 different food groups, ten groups that protect brain health and five groups that harm brain health. By examining the Food Frequency Questionnaire of individuals, the amount of consumption of foods belonging to these 15 groups was divided into portions and evaluated in accordance with the scoring. It is scored between 0-15 and there is no cut-off point for determining compliance with the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet. It has been reported that the higher the score, the higher the compliance with the MIND diet. The Food Frequency Questionnaire of the items reflecting each MIND diet component were quantified in terms of how many days per week individuals consumed the food item.
Measured: 4 months
Geriatric Nutritional Risk Index (GNRI)
It was first introduced to evaluate the nutritional status of elderly, bedridden care patients. GNRI is calculated using height, weight and serum albumin values of the patients. GNRI [1.489 x albumin (g/l)] + [ 41.7 x (body weight / ideal body weight)]. According to the GNRI results, they are divided into four groups. Malnutrition grades are grouped as GNRI<82; severe malnutrition, moderate malnutrition between 82-92, mild malnutrition between 92-98, and no risk for malnutrition above 98.
Measured: 4 months
Mini Nutritional Assessment-Short Form (MNA-SF)
It is a screening tool used to evaluate malnutrition in elderly individuals. The tool includes six items that assess various factors such as appetite changes, unintentional weight loss over the past three months, neuropsychological issues, presence of psychological stress or acute illness, mobility, and BMI. Based on the total score, individuals are categorized into three nutritional status groups: 0-7 points: Malnourished (indicating nutritional deficiency), 8-11 points: At risk of malnutrition, 12-14 points: Normal nutritional status.
Measured: 4 months
Beck Depression Inventory (BDI)
The BDI was developed to measure behavioral symptoms of depression in adolescents and adults. The inventory was revised to remove repetitive statements describing severity levels and to ask individuals to assess not only their mood on that day but also their mood over the past week. The scores obtained from the inventory are classified as follows to determine the severity of depression: 0-9 points: Minimal depression, 10-16 points: Mild depression, 17-29 points: Moderate depression, 30-63 points: Severe depression.
Measured: 4 months
Beck Anxiety Inventory (BAI)
It was originally developed to assess the intensity and frequency of anxiety symptoms reported by individuals. This self-assessment tool comprises 21 items, each rated on a scale from 0 (not at all) to 3 (severely). The total possible score ranges between 0 and 63, and the anxiety level is interpreted based on the total score as follows: 0-7: Minimal anxiety, 8-15: Mild anxiety, 16-22: Moderate anxiety, 23-63: Severe anxiety.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Jun 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurefşan KONYALIGİL ÖZTÜRK, Abant Izzet Baysal University
- Investigators
- Nurefşan Konyalıgil Öztürk, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163923
- Sponsor's protocol ID
- AIBU-BD-NKÖ-01
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the MIND Diet in Alzheimer's Disease Patients: A Case-Control Study on Malnutrition and Depression
- ClinicalTrials.gov ID
- NCT07163923
- Acronym / sponsor ID
- AIBU-BD-NKÖ-01
- Keywords
- Alzheimer disease, Depression, Diet, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 9 Sep 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.
The aim of this study was to examine the association between depression, malnutrition, and the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet in Alzheimer's disease patients. This study included 30 patients with Alzheimer's disease (AD) and 30 healthy controls. A questionnaire form including sociodemographic characteristics was applied to the individuals. In addition, anthropometric measurements, biochemical parameters, nutritional status (Food Frequency Questionnaire (FFQ), Mini Nutritional Assessment-Short Form (MNA-SF), Geriatric Nutritional Risk Index (GNRI) and MIND diet scores) and mental health status (Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI)).
Detailed description
Significant progress has been made in understanding the neurobiological basis and treatment approaches for Alzheimer's disease (AD) and depression; however, the biological link between these two disorders has not yet been fully elucidated. A deeper understanding of this relationship could contribute to the development of more effective strategies for the prevention and treatment of both conditions. In this context, lifestyle-based interventions, such as nutrition, which have been shown to support cognitive health, emerge as a potential preventive and therapeutic approach. Therefore, the aim of this study was to examine the relationship between depression, malnutrition, and the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet in individuals with AD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease Patients | – | –Participants diagnosed with Alzheimer's disease according to established clinical criteria. Evaluated for malnutrition and depression status. No intervention was applied. |
| Healthy Controls | – | –Age- and sex-matched individuals without Alzheimer's disease. Evaluated for malnutrition and depression status. No intervention was applied. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study was planned as a case-control study. The study was conducted on healthy individuals with AD who were admitted to Bolu Abant İzzet Baysal University Training and Research Hospital Neurology Outpatient Clinic and volunteered to participate in the study. In the study, according to the 5% significance level (α = 0.05), 80% statistical power (1-β = 0.80) and sample size calculation for two groups (AD and control group), it was determined that at least 30 individuals should be included in each group in order to detect a medium-large effect size (Cohen's d ≈ 0.66). Therefore, 30 AD and 30 healthy individuals (control group) who volunteered to participate in the study were included.
Key inclusion criteria (5 listed)
- Patients aged over 60 years.
- Diagnosed with Alzheimer's disease (AD) (for AD group)
- Able to communicate with themselves or their companions
- Healthy volunteers without systemic or neurological diseases (for control group)
- Matching criteria: Age, gender, smoking status, and alcohol use
Key exclusion criteria (7 listed)
- Chronic inflammatory diseases
- Schizophrenia
- Bipolar disorder
- Amputations
- Neoplastic disorders
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
Questionnaire Form
Time frame: 4 months
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.
Body weight (BW)
Time frame: 4 months
BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.
Height
Time frame: 4 months
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Waist Circumference (WC)
Time frame: 4 months
WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.
Hip Circumference (HC)
Time frame: 4 months
HC was measured at the widest point of the hips using a flexible measuring tape.
Body Mass Index (BMI)
Time frame: 4 months
BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).
Fasting Blood Glucose
Time frame: 4 months
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Triglycerides
Time frame: 4 months
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
LDL-Cholesterol
Time frame: 4 months
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Total Cholesterol
Time frame: 4 months
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
Albumin
Time frame: 4 months
Serum albumin levels were measured using routine laboratory procedures in outpatient visits.
Vitamin D
Time frame: 4 months
Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.
Folic Acid
Time frame: 4 months
Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.
Vitamin B12
Time frame: 4 months
Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.
Food Frequency Questionnaire
Time frame: 4 months
The foods consumed by individuals in the last month were evaluated across seven different groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugar and fats), beverages, and fast food. Participants were asked how often they consumed foods and beverages in these groups; responses were collected using the following options: "every meal," "every day," "5-6 days a week," "3-4 days a week," "1-2 days a week," "once every 15 days," "once a month," and "never." To determine the average daily consumption amounts based on consumption frequency, the following coefficients were used: 3 for "every meal," 1 for "every day," 0.7855 for "5-6 times a week," 0.498 for "3-4 times a week," 0.2145 for "1-2 times a week," 0.067 for "every 15 days," and 0.033 for "once a month."
MIND diet compliance score
Time frame: 4 months
It includes a total of 15 different food groups, ten groups that protect brain health and five groups that harm brain health. By examining the Food Frequency Questionnaire of individuals, the amount of consumption of foods belonging to these 15 groups was divided into portions and evaluated in accordance with the scoring. It is scored between 0-15 and there is no cut-off point for determining compliance with the Mediterranean-Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay (MIND) diet. It has been reported that the higher the score, the higher the compliance with the MIND diet. The Food Frequency Questionnaire of the items reflecting each MIND diet component were quantified in terms of how many days per week individuals consumed the food item.
Geriatric Nutritional Risk Index (GNRI)
Time frame: 4 months
It was first introduced to evaluate the nutritional status of elderly, bedridden care patients. GNRI is calculated using height, weight and serum albumin values of the patients. GNRI [1.489 x albumin (g/l)] + [ 41.7 x (body weight / ideal body weight)]. According to the GNRI results, they are divided into four groups. Malnutrition grades are grouped as GNRI<82; severe malnutrition, moderate malnutrition between 82-92, mild malnutrition between 92-98, and no risk for malnutrition above 98.
Mini Nutritional Assessment-Short Form (MNA-SF)
Time frame: 4 months
It is a screening tool used to evaluate malnutrition in elderly individuals. The tool includes six items that assess various factors such as appetite changes, unintentional weight loss over the past three months, neuropsychological issues, presence of psychological stress or acute illness, mobility, and BMI. Based on the total score, individuals are categorized into three nutritional status groups: 0-7 points: Malnourished (indicating nutritional deficiency), 8-11 points: At risk of malnutrition, 12-14 points: Normal nutritional status.
Beck Depression Inventory (BDI)
Time frame: 4 months
The BDI was developed to measure behavioral symptoms of depression in adolescents and adults. The inventory was revised to remove repetitive statements describing severity levels and to ask individuals to assess not only their mood on that day but also their mood over the past week. The scores obtained from the inventory are classified as follows to determine the severity of depression: 0-9 points: Minimal depression, 10-16 points: Mild depression, 17-29 points: Moderate depression, 30-63 points: Severe depression.
Beck Anxiety Inventory (BAI)
Time frame: 4 months
It was originally developed to assess the intensity and frequency of anxiety symptoms reported by individuals. This self-assessment tool comprises 21 items, each rated on a scale from 0 (not at all) to 3 (severely). The total possible score ranges between 0 and 63, and the anxiety level is interpreted based on the total score as follows: 0-7: Minimal anxiety, 8-15: Mild anxiety, 16-22: Moderate anxiety, 23-63: Severe anxiety.
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 9 Sep 2025.
- 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.
Nurefşan Konyalıgil Öztürk principal investigator
Abant Izzet Baysal University
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 Alzheimer Disease (AD) and Healthy Controls Group - Age and Sex-matched, run by Abant Izzet Baysal 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 5 inclusion and 7 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 9 Sep 2025. 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?
Questionnaire Form (time frame: 4 months). The study lists 20 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 9 Sep 2025.