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

Kardelen Kandemir

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM); Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled

Treatments: Other: DASH Diet; Other: Türkiye Nutrition Guideline Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07101406

28.06.2024-993310

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Active Comparator: Türkiye Nutrition Guideline Diet Group

Active Comparator group

Description:

Participants followed a diet based on the Türkiye Nutrition Guideline (TÜBER) for pregnancy. The diet consisted of 45-60% carbohydrates, 12-20% protein (minimum 70 g), and 20-35% fat. Portion sizes were explained during the initial consultation. Participants recorded their food intake weekly and attended weekly follow-up visits for anthropometric and blood pressure measurements. Diets were adjusted weekly based on blood glucose levels.

Treatment:

Other: Türkiye Nutrition Guideline Diet

Active Comparator: DASH Diet Group

Active Comparator group

Description:

Participants followed a diet based on the Dietary Approaches to Stop Hypertension (DASH) guidelines. The diet consisted of 45-60% carbohydrates (minimum 175 g), 12-20% protein (minimum 70 g), and 20-35% fat including 6% saturated fat and 150 mg cholesterol. It was low in sodium (2300 mg/day) and rich in potassium (4700 mg), calcium (1250 mg), and magnesium (500 mg). It emphasized low-fat dairy, lean meats, 10 servings/day of fruits and vegetables, and 4-5 servings/week of nuts, seeds, and legumes. Weekly follow-ups were conducted as in the other group.

Treatment:

Other: DASH Diet