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

NCT07101406 | Completed DMC

• 1 other identifier: 28.06.2024-993310
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

gestational diabetes; dash diet; Türkiye Nutrition Guide; diet

Outcome Measures

Primary Outcomes (1)

• Change in fasting blood glucose levels

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

  Daily for 4 weeks

Secondary Outcomes (7)

• Change in 1-hour postprandial blood glucose levels

  Daily for 4 weeks

• Change in fasting insulin level

  Baseline and Week 4

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

  Baseline and weekly over 4 weeks

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

  Baseline and Week 4

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

  Baseline and Week 4

Study Arms (2)

Active Comparator: Türkiye Nutrition Guideline Diet Group

ACTIVE COMPARATOR

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.

Other: Türkiye Nutrition Guideline Diet

Active Comparator: DASH Diet Group

ACTIVE COMPARATOR

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.

Other: DASH Diet

Interventions

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.

Active Comparator: Türkiye Nutrition Guideline Diet Group

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.

Active Comparator: DASH Diet Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kardelen Kandemir: lead

Study Sites (1)

Atlas Univercity Hospital

Istanbul, Bagcılar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Asisstant (Dietitian)

Model Details: Randomized single-blind. Participants were blinded.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 3, 2025
• Study Start: June 1, 2024
• Primary Completion: May 20, 2025
• Study Completion: July 22, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

TU (1)