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Completed

NCT Number: NCT07310225

Mediterranean Diet vs DASH and MIND in T2DM

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant İzzet Baysal University, Faculty of Health Sciences

Bolu, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention (observational study)

Other

No intervention (observational study)

Primary outcomes

  1. Questionnaire Form

    Time frame: 9 months

    Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use) were questioned.

  2. 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.

  3. 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.

  4. 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.

  5. Hip Circumference (HC)

    Time frame: 9 months

    HC was measured at the widest point of the hips using a flexible measuring tape.

  6. 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).

  7. Fasting Blood Glucose

    Time frame: 9 months

    Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

  8. Triglycerides

    Time frame: 9 months

    Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.

  9. LDL-Cholesterol

    Time frame: 9 months

    LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.

  10. Total Cholesterol

    Time frame: 9 months

    Total cholesterol was measured using routine biochemical analysis in a certified laboratory.

  11. HbA1c (%)

    Time frame: 9 months

    Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

  12. 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)

  13. Body Fat Mass (FM) (%)

    Time frame: 9 months

    Obtained using a bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

  14. Basal Metabolic Rate (BMR) (kcal)

    Time frame: 9 months

    Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan) was used.

  15. Fat-Free Mass (FFM) (kg)

    Time frame: 9 months

    bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

  16. Visceral Fat Area (VFA) (%)

    Time frame: 9 months

    Bioelectrical impedance analysis (BIA) device (Tanita Innerscan BC 401, Japan).

  17. 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.

  18. 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.

  19. 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'.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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