- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310225
Mediterranean Diet vs DASH and MIND in T2DM
December 16, 2025 updated by: Nurefşan KONYALIGİL ÖZTÜRK, Abant Izzet Baysal University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bolu, Turkey (Türkiye)
- Bolu Abant İzzet Baysal University, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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)).
Description
Inclusion Criteria:
- Individuals over 19 years of age
- Individuals who are literate
- Individuals diagnosed with Type 2 diabetes
Exclusion Criteria:
- Individuals who have had an acute infection or inflammatory disease within the past month
- Individuals with chronic infectious or inflammatory diseases
- Individuals with cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals with Type 2 diabetes
This cohort includes adult participants diagnosed with Type 2 diabetes.
No control group is included.
|
No intervention (observational study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire Form
Time Frame: 9 months
|
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use) were questioned.
|
9 months
|
|
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.
|
9 months
|
|
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.
|
9 months
|
|
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.
|
9 months
|
|
Hip Circumference (HC)
Time Frame: 9 months
|
HC was measured at the widest point of the hips using a flexible measuring tape.
|
9 months
|
|
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).
|
9 months
|
|
Fasting Blood Glucose
Time Frame: 9 months
|
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
|
9 months
|
|
Triglycerides
Time Frame: 9 months
|
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
|
9 months
|
|
LDL-Cholesterol
Time Frame: 9 months
|
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
|
9 months
|
|
Total Cholesterol
Time Frame: 9 months
|
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
|
9 months
|
|
HbA1c (%)
Time Frame: 9 months
|
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
|
9 months
|
|
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)
|
9 months
|
|
Body Fat Mass (FM) (%)
Time Frame: 9 months
|
Obtained using a bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
|
9 months
|
|
Basal Metabolic Rate (BMR) (kcal)
Time Frame: 9 months
|
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan) was used.
|
9 months
|
|
Fat-Free Mass (FFM) (kg)
Time Frame: 9 months
|
bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
|
9 months
|
|
Visceral Fat Area (VFA) (%)
Time Frame: 9 months
|
Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).
|
9 months
|
|
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.
|
9 months
|
|
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.
|
9 months
|
|
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'.
|
9 months
|
|
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.
|
9 months
|
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
December 16, 2025
First Submitted That Met QC Criteria
December 16, 2025
First Posted (Actual)
December 30, 2025
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 16, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-BD-NKÖ-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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