Type 2 DiabetesNCT07310225
Mediterranean Diet vs DASH and MIND in T2DM
An observational study of Type 2 Diabetes, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to comparatively evaluate the relative effects of the Mediterranean, DASH, and MIND diets on metabolic parameters in individuals with type 2 diabetes. The study was conducted on 90 individuals diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Sep 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was designed as a cross-sectional descriptive study. The study included patients who presented to the Internal Medicine Outpatient Clinic at BAİBÜ İzzet Baysal Education and Research Hospital and diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood glucose ≥ 126 mg/dL, 2-hour blood glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or HbA1c ≥ 6.5% (48 mmol/mol)).
Who may be able to join
- Individuals over 19 years of age
- Individuals who are literate
- Individuals diagnosed with Type 2 diabetes
Who cannot join
- Individuals who have had an acute infection or inflammatory disease within the past month
- Individuals with chronic infectious or inflammatory diseases
- Individuals with cancer
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 Effect of the Mediterranean Diet on Metabolic Parameters in Individuals With Type 2 Diabetes: A Comparative Evaluation With the DASH and MIND Diets
In our study, we aimed to comparatively evaluate the relative effects of the Mediterranean, DASH, and MIND diets on metabolic parameters in individuals with type 2 diabetes. The study was conducted on 90 individuals diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood glucose ≥ 126 mg/dL, 2-hour blood glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or HbA1c ≥ 6.5% (48 mmol/mol)). Volunteers who participated in the study completed a questionnaire form that included sociodemographic characteristics. In addition, participants' anthropometric measurements (body weight (BW), height, waist circumference (WC), hip circumference (HC), body mass index (BMI)), biochemical parameters (fasting blood glucose, hbA1c (%), LDL-cholesterol, triglycerides, total cholesterol), Visceral Adiposity Index (VAİ), body composition analyses (Fat Mass (FM (%), Fat-Free Mass (FFM) (kg), Basal Metabolic Rate (BMR) (kcal), Visceral Fat Area (VFA) (%)), nutritional status (food consumption frequency, food consumption record, Mediterranean Diet Scale, DASH diet adherence score, and MIND diet adherence score) were evaluated.
- Conditions
- Type 2 Diabetes
- Being tested
- No intervention (observational study)
- Keywords
- Mediterranean diet, DASH diet, MIND diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Type 2 diabetes | This cohort includes adult participants diagnosed with Type 2 diabetes. No control group is included. Receives: Other: No intervention (observational study) |
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) were questioned.
Measured: 9 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: 9 months
Height
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Measured: 9 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: 9 months
Hip Circumference (HC)
HC was measured at the widest point of the hips using a flexible measuring tape.
Measured: 9 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: 9 months
Fasting Blood Glucose
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Measured: 9 months
Triglycerides
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
Measured: 9 months
LDL-Cholesterol
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Measured: 9 months
Total Cholesterol
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
Measured: 9 months
HbA1c (%)
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Measured: 9 months
Abdominal obesity index (VAI)
Abdominal obesity index (VAI): VAI has been used to assess abdominal obesity. VAI (Men) = [Waist circumference (cm) / (36.58 + (1.88 × BMI)] × (triglycerides / 1.03) × (1.31 / HDL-C) , VAI (Women) = [Waist circumference (cm) / (36.58 + (1.88 × BMI)] × (triglycerides / 0.81) × (1.52 / HDL-C)
Measured: 9 months
Body Fat Mass (FM) (%)
Obtained using a bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Measured: 9 months
Basal Metabolic Rate (BMR) (kcal)
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan) was used.
Measured: 9 months
Fat-Free Mass (FFM) (kg)
bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Measured: 9 months
Visceral Fat Area (VFA) (%)
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Measured: 9 months
Food consumption frequency
Participants were asked about the foods they consumed in the past month from seven groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugars and fats), beverages, and fast food. Participants were asked how often and in what quantities they consumed these foods using eight 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." In evaluating food consumption records, responses regarding food consumption frequency were calculated using food consumption frequency. The amounts of food and beverages consumed were multiplied by "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 "once every 15 days," and "0.033" for "once a month" to obtain the daily average amounts.
Measured: 9 months
Food consumption record
A single-day food consumption record was obtained using the 24-hour recall method to determine participants' food consumption patterns. The Food and Nutrition Photo Catalog was used to estimate portions to ensure that the amounts of food consumed were assessed accurately and reliably. Based on these records, daily energy and nutrient intakes were calculated using the Nutrition Information System (BEBİS) software, based on the type and amount of food consumed by individuals in the last 24 hours.
Measured: 9 months
DASH diet compliance
Individuals' DASH diet compliance scores were calculated based on their food consumption frequency after their energy requirements were calculated. The highest possible score on the DASH diet compliance scale is 8.0. A score of 4.5 or above is considered 'high compliance', while a score below 4.5 is considered 'low compliance'.
Measured: 9 months
Mediterranean diet adherence scale
The Mediterranean Diet Scale was used to determine individuals' adherence to the Mediterranean diet. This scale consists of a total of 14 questions, 2 of which relate to food consumption habits and 12 of which relate to food consumption frequency. Each question is scored as either 0 or 1 point. The scale's scoring range is set at 0-14 points.
Measured: 9 months
MIND diet compliance score
It includes a total of 15 different food groups, consisting of ten groups that protect brain health and five groups that harm brain health. Individuals' food consumption records and frequency of food consumption were examined, and the consumption amounts of foods belonging to these 15 groups were divided into portions and evaluated according to the scoring system. This scale is scored from 0 to 15, and there is no cutoff point for determining compliance with the MIND diet.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310225
- Sponsor's protocol ID
- AIBU-BD-NKÖ-03
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mediterranean Diet on Metabolic Parameters in Individuals With Type 2 Diabetes: A Comparative Evaluation With the DASH and MIND Diets
- ClinicalTrials.gov ID
- NCT07310225
- Acronym / sponsor ID
- AIBU-BD-NKÖ-03
- Conditions
- Type 2 Diabetes
- Keywords
- Mediterranean diet, DASH diet, MIND diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Dec 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.
In our study, we aimed to comparatively evaluate the relative effects of the Mediterranean, DASH, and MIND diets on metabolic parameters in individuals with type 2 diabetes. The study was conducted on 90 individuals diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood glucose ≥ 126 mg/dL, 2-hour blood glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or HbA1c ≥ 6.5% (48 mmol/mol)). Volunteers who participated in the study completed a questionnaire form that included sociodemographic characteristics. In addition, participants' anthropometric measurements (body weight (BW), height, waist circumference (WC), hip circumference (HC), body mass index (BMI)), biochemical parameters (fasting blood glucose, hbA1c (%), LDL-cholesterol, triglycerides, total cholesterol), Visceral Adiposity Index (VAİ), body composition analyses (Fat Mass (FM (%), Fat-Free Mass (FFM) (kg), Basal Metabolic Rate (BMR) (kcal), Visceral Fat Area (VFA) (%)), nutritional status (food consumption frequency, food consumption record, Mediterranean Diet Scale, DASH diet adherence score, and MIND diet adherence score) were evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Type 2 diabetes | – | Other: No intervention (observational study)This cohort includes adult participants diagnosed with Type 2 diabetes. No control group is included. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was designed as a cross-sectional descriptive study. The study included patients who presented to the Internal Medicine Outpatient Clinic at BAİBÜ İzzet Baysal Education and Research Hospital and diagnosed with T2DM according to the American Diabetes Association diagnostic criteria (fasting blood glucose ≥ 126 mg/dL, 2-hour blood glucose ≥ 200 mg/dL during an oral glucose tolerance test (OGTT), or HbA1c ≥ 6.5% (48 mmol/mol)).
Key inclusion criteria (3 listed)
- Individuals over 19 years of age
- Individuals who are literate
- Individuals diagnosed with Type 2 diabetes
Key exclusion criteria (3 listed)
- Individuals who have had an acute infection or inflammatory disease within the past month
- Individuals with chronic infectious or inflammatory diseases
- Individuals with cancer
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Individuals with Type 2 diabetes |
Primary outcome
Questionnaire Form
Time frame: 9 months
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use) were questioned.
Body Weight (BW)
Time frame: 9 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: 9 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: 9 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: 9 months
HC was measured at the widest point of the hips using a flexible measuring tape.
Body Mass Index (BMI)
Time frame: 9 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: 9 months
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Triglycerides
Time frame: 9 months
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
LDL-Cholesterol
Time frame: 9 months
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Total Cholesterol
Time frame: 9 months
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
HbA1c (%)
Time frame: 9 months
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Abdominal obesity index (VAI)
Time frame: 9 months
Abdominal obesity index (VAI): VAI has been used to assess abdominal obesity. VAI (Men) = [Waist circumference (cm) / (36.58 + (1.88 × BMI)] × (triglycerides / 1.03) × (1.31 / HDL-C) , VAI (Women) = [Waist circumference (cm) / (36.58 + (1.88 × BMI)] × (triglycerides / 0.81) × (1.52 / HDL-C)
Body Fat Mass (FM) (%)
Time frame: 9 months
Obtained using a bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Basal Metabolic Rate (BMR) (kcal)
Time frame: 9 months
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan) was used.
Fat-Free Mass (FFM) (kg)
Time frame: 9 months
bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Visceral Fat Area (VFA) (%)
Time frame: 9 months
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
Food consumption frequency
Time frame: 9 months
Participants were asked about the foods they consumed in the past month from seven groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugars and fats), beverages, and fast food. Participants were asked how often and in what quantities they consumed these foods using eight 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." In evaluating food consumption records, responses regarding food consumption frequency were calculated using food consumption frequency. The amounts of food and beverages consumed were multiplied by "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 "once every 15 days," and "0.033" for "once a month" to obtain the daily average amounts.
Food consumption record
Time frame: 9 months
A single-day food consumption record was obtained using the 24-hour recall method to determine participants' food consumption patterns. The Food and Nutrition Photo Catalog was used to estimate portions to ensure that the amounts of food consumed were assessed accurately and reliably. Based on these records, daily energy and nutrient intakes were calculated using the Nutrition Information System (BEBİS) software, based on the type and amount of food consumed by individuals in the last 24 hours.
DASH diet compliance
Time frame: 9 months
Individuals' DASH diet compliance scores were calculated based on their food consumption frequency after their energy requirements were calculated. The highest possible score on the DASH diet compliance scale is 8.0. A score of 4.5 or above is considered 'high compliance', while a score below 4.5 is considered 'low compliance'.
Mediterranean diet adherence scale
Time frame: 9 months
The Mediterranean Diet Scale was used to determine individuals' adherence to the Mediterranean diet. This scale consists of a total of 14 questions, 2 of which relate to food consumption habits and 12 of which relate to food consumption frequency. Each question is scored as either 0 or 1 point. The scale's scoring range is set at 0-14 points.
MIND diet compliance score
Time frame: 9 months
It includes a total of 15 different food groups, consisting of ten groups that protect brain health and five groups that harm brain health. Individuals' food consumption records and frequency of food consumption were examined, and the consumption amounts of foods belonging to these 15 groups were divided into portions and evaluated according to the scoring system. This scale is scored from 0 to 15, and there is no cutoff point for determining compliance with the MIND diet.
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 30 Dec 2025.
Related trials for Type 2 Diabetes
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
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 Type 2 Diabetes, 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 3 inclusion and 3 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 30 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 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: 9 months). The study lists 21 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 30 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.