Gestational Diabetes Mellitus (GDM)NCT07101406
The Effect of TUBER Recommendations and the DASH Diet on Blood Parameters in Patients With Gestational Diabetes
A study testing Türkiye Nutrition Guideline Diet and DASH Diet in people with Gestational Diabetes Mellitus (GDM) and Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, run by Kardelen Kandemir at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
- What is being tested?
- Türkiye Nutrition Guideline Diet and DASH Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18 to 35 years
- Singleton pregnancy
- Clinical diagnosis of gestational diabetes mellitus (GDM)
- Ability to use a glucometer
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Türkiye Nutrition Guideline Diet, DASH Diet
- Keywords
- gestational diabetes, dash diet, Türkiye Nutrition Guide, diet
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Türkiye Nutrition Guideline DietOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: DASH Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose levels
To monitor daily fasting blood glucose levels (mg/dL) using a glucometer throughout the 4-week intervention.
Measured: Daily for 4 weeks
Secondary outcomes (7)
Change in 1-hour postprandial blood glucose levels
To track 1-hour post-meal blood glucose levels (mg/dL) recorded daily throughout the study.
Measured: Daily for 4 weeks
Change in fasting insulin level
To evaluate changes in fasting insulin levels (µIU/mL) from baseline to the end of the 4-week intervention period.
Measured: Baseline and Week 4
Change in daily energy and nutrient intake based on 24-Hour Food Consumption Record
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.)
Measured: Baseline and weekly over 4 weeks
Change in lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
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)
Measured: Baseline and Week 4
Change in iron-related parameters (iron, ferritin, total iron-binding capacity)
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
Measured: Baseline and Week 4
Change in vitamin and hematological markers (Vitamin D, folic acid, hemoglobin, hematocrit)
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: %
Measured: Baseline and Week 4
Change in HbA1c level
To assess the effect of the dietary intervention on long-term glycemic control by measuring HbA1c levels (%) before and after the intervention.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jun 2024
- Primary completion20 May 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized single-blind. Participants were blinded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kardelen Kandemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kardelen Kandemir, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101406
- Sponsor's protocol ID
- 28.06.2024-993310
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TUBER Recommendations and the DASH Diet on Blood Parameters in Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07101406
- Acronym / sponsor ID
- 28.06.2024-993310
- Conditions
- Gestational Diabetes Mellitus (GDM), Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
- Keywords
- gestational diabetes, dash diet, Türkiye Nutrition Guide, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kardelen KandemirUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized single-blind. Participants were blinded.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Türkiye Nutrition Guideline Diet Group | Active comparator | Other: Türkiye Nutrition Guideline DietParticipants 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. |
| Active Comparator: DASH Diet Group | Active comparator | Other: DASH DietParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female participants aged 18 to 35 years
- Singleton pregnancy
- Clinical diagnosis of gestational diabetes mellitus (GDM)
- Ability to use a glucometer
Key exclusion criteria (7 listed)
- Pre-gestational diabetes or impaired glucose tolerance (IGT)
- Hypoglycemia
- Receiving insulin therapy
- Development of preeclampsia
- Failure to adhere to the prescribed diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Türkiye Nutrition Guideline DietA 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. | Other | Active Comparator: Türkiye Nutrition Guideline Diet Group |
| DASH DietA 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. | Other | Active Comparator: DASH Diet Group |
Primary outcome
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.
7 secondary outcomes
Change in 1-hour postprandial blood glucose levels
Time frame: Daily for 4 weeks
Change in fasting insulin level
Time frame: Baseline and Week 4
Change in daily energy and nutrient intake based on 24-Hour Food Consumption Record
Time frame: Baseline and weekly over 4 weeks
Change in lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
Time frame: Baseline and Week 4
Change in iron-related parameters (iron, ferritin, total iron-binding capacity)
Time frame: Baseline and Week 4
Change in vitamin and hematological markers (Vitamin D, folic acid, hemoglobin, hematocrit)
Time frame: Baseline and Week 4
Change in HbA1c level
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Türkiye Nutrition Guideline Diet and DASH Diet in people with Gestational Diabetes Mellitus (GDM) and Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, run by Kardelen Kandemir at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose levels (time frame: Daily for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.