NCT07163923|Completed
MIND Diet in Relation to Malnutrition and Depression in AD
The Role of the MIND Diet in Alzheimer's Disease Patients: A Case-Control Study on Malnutrition and Depression
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The Role of the MIND Diet in Alzheimer's Disease Patients: A Case-Control Study on Malnutrition and Depression
Sponsor study identifier
observational
60
1 country
1
Study Start
June 15, 2024
Actual (reported)Primary Completion
October 15, 2024
Actual (reported)Study Completion
October 15, 2024
Actual (reported)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)).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2024
Actual (reported)October 15, 2024
Actual (reported)October 15, 2024
Actual (reported)August 28, 2025
Actual (reported)September 9, 2025
Actual (reported)Questionnaire Form
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.
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.
4 months
Height
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
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.
4 months
Participants diagnosed with Alzheimer's disease according to established clinical criteria. Evaluated for malnutrition and depression status. No intervention was applied.
Age- and sex-matched individuals without Alzheimer's disease. Evaluated for malnutrition and depression status. No intervention was applied.
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.
Bolu Abant İzzet Baysal University, Faculty of Health Sciences
Bolu, Turkey (Türkiye)
Nurefşan Konyalıgil Öztürk
Abant Izzet Baysal University
60 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2025
First Posted
September 9, 2025
Study Start
June 15, 2024
Actual (reported)Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters
Hip Circumference (HC)
HC was measured at the widest point of the hips using a flexible measuring tape.
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).
4 months
Fasting Blood Glucose
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
4 months
Triglycerides
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
4 months
LDL-Cholesterol
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
4 months
Total Cholesterol
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
4 months
Albumin
Serum albumin levels were measured using routine laboratory procedures in outpatient visits.
4 months
Vitamin D
Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.
4 months
Folic Acid
Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.
4 months
Vitamin B12
Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.
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."
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.
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.
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.
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.
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.
4 months
Contact the study team to confirm eligibility.
Primary Completion
October 15, 2024
Actual (reported)Study Completion
October 15, 2024
Actual (reported)Last Updated
September 9, 2025
Record last verified: 2025-09
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