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NCT Number: NCT07101406

The Effect of TUBER Recommendations and the DASH Diet on Blood Parameters in Patients With Gestational Diabetes

The aim of this clinical trial was to examine the effects of the Turkish Nutrition Guide Recommendations Diet and the DASH Diet on blood sugar, blood pressure, and biochemical parameters in patients with gestational diabetes. The study hypotheses are as follows:

Hypothesis 1: The DASH diet reduces fasting blood glucose levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Türkiye.

Hypothesis 1: The DASH diet reduces insulin levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Turkey.

Hypothesis 1: The DASH diet reduces HbA1c levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Türkiye.

Hypothesis 1: The Dash diet reduces 1st-hour postprandial glucose levels more significantly in women with gestational diabetes compared to a diet adapted to a healthy diet typical of Türkiye.

Participants:

After being diagnosed with gestational diabetes by a doctor using an OGTT test at 24-28 weeks, the researcher will complete a general information form during their first consultation with the dietitian. For four weeks, the dietitian will follow the diets created by the researcher based on their assigned diet group in a blinded manner. They will record their fasting and postprandial blood sugar levels in the morning, noon, evening, night, and during snacks, if they are taking them. They will keep a 24-hour food consumption record before meeting with the researcher weekly. Participants will have their biochemical parameters assessed at the beginning of the study and at the end of the fourth week.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlas Univercity Hospital

Istanbul, Bagcılar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female participants aged 18 to 35 years
  • Singleton pregnancy
  • Clinical diagnosis of gestational diabetes mellitus (GDM)
  • Ability to use a glucometer

Exclusion criteria

  • Pre-gestational diabetes or impaired glucose tolerance (IGT)
  • Hypoglycemia
  • Receiving insulin therapy
  • Development of preeclampsia
  • Failure to adhere to the prescribed diet
  • Smoking
  • Alcohol consumption

Treatment and study plan

Türkiye Nutrition Guideline Diet

Other

A diet structured according to the Türkiye Nutrition Guideline (TÜBER) for pregnant women, consisting of 45-60% carbohydrates, 12-20% protein (minimum 70 g), and 20-35% fat. Diets were tailored weekly based on blood glucose levels and individual dietary intake records.

DASH diet

Other

A dietary plan based on DASH guidelines: 45-60% carbohydrates (≥175 g), 12-20% protein (≥70 g), 20-35% fat (≤6% saturated), ≤2300 mg sodium, ≥4700 mg potassium, ≥1250 mg calcium, ≥500 mg magnesium. Includes low-fat dairy, lean meats, fruits/vegetables, and nuts/seeds.

Primary outcomes

  1. Change in fasting blood glucose levels

    Time frame: Daily for 4 weeks

    To monitor daily fasting blood glucose levels (mg/dL) using a glucometer throughout the 4-week intervention.

Secondary outcomes

  1. Change in 1-hour postprandial blood glucose levels

    Time frame: Daily for 4 weeks

    To track 1-hour post-meal blood glucose levels (mg/dL) recorded daily throughout the study.

  2. Change in fasting insulin level

    Time frame: Baseline and Week 4

    To evaluate changes in fasting insulin levels (µIU/mL) from baseline to the end of the 4-week intervention period.

  3. Change in daily energy and nutrient intake based on 24-Hour Food Consumption Record

    Time frame: Baseline and weekly over 4 weeks

    To assess participants' dietary intake patterns and nutrient adequacy by analyzing the 24-Hour Food Consumption Record collected at baseline and during follow-up. The analysis includes total daily energy intake (kcal) and macronutrient (carbohydrates, protein, fat) and micronutrient (iron, folic acid, vitamin D, etc.) intake levels.

    Energy: kcal/day

    Macronutrients: grams/day (carbohydrates, protein, fat)

    Micronutrients: mg or µg/day (iron, folic acid, vitamin D, etc.)

  4. Change in lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)

    Time frame: Baseline and Week 4

    To evaluate the effect of the dietary intervention on lipid metabolism by measuring changes in total cholesterol, HDL cholesterol, LDL cholesterol (direct measurement), and triglyceride levels from baseline to week 4. Each parameter will be analyzed individually and reported in mg/dL.

    Total cholesterol (mg/dL)

    HDL cholesterol (mg/dL)

    LDL cholesterol - direct measurement (mg/dL)

    Triglycerides (mg/dL)

  5. Change in iron-related parameters (iron, ferritin, total iron-binding capacity)

    Time frame: Baseline and Week 4

    To assess the effect of the intervention on iron status by measuring serum iron, ferritin, and total iron-binding capacity (TIBC) at baseline and Week 4.

    Iron: mcg/dL

    Ferritin: mcg/L

    TIBC: mcg/dL

  6. Change in vitamin and hematological markers (Vitamin D, folic acid, hemoglobin, hematocrit)

    Time frame: Baseline and Week 4

    To evaluate changes in nutritional and hematological status from baseline to the end of the intervention period.

    25-OH vitamin D: mcg/L

    Folic acid: mcg/dL

    Hemoglobin: g/dL

    Hematocrit: %

  7. Change in HbA1c level

    Time frame: Baseline and Week 4

    To assess the effect of the dietary intervention on long-term glycemic control by measuring HbA1c levels (%) before and after the intervention.

Sponsors and collaborators

Lead sponsor

Kardelen Kandemir

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 7, 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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