Type 1 Diabetes (Juvenile Onset)MEDOX-T1DNCT07544368
Mediterranean Diet and Oxidative Stress in Type 1 Diabetes (MEDOX-T1D)
A study testing Mediterranean Diet Intervention in people with Type 1 Diabetes (Juvenile Onset) and Continuous Glucose Monitoring System, run by Istanbul University.
Trial summary
Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Type 1 Diabetes (Juvenile Onset), Continuous Glucose Monitoring System, Oxidative Stress
- What is being tested?
- Mediterranean Diet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 10-18 years
- BMI between the 5th and 95th percentile (normal to overweight)
- Diagnosis of Type 1 Diabetes for ≥1.5 years
- Users of a continuous glucose monitoring (CGM) system
- No other comorbidities and not taking medications
- Non-smokers and non-alcohol users (including e-cigarettes)
- Written informed consent provided by the participant and their parent/guardian
Who cannot join
- Presence of any acute or chronic disease other than Type 1 Diabetes
- Current use of any medications
- BMI ≥ 95th percentile (obese)
- Presence of an eating disorder
- Use of tobacco, e-cigarettes, or alcohol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship Between Adherence to the Mediterranean Diet and Oxidative Stress in Children With Type 1 Diabetes
Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c > 7%) and whose adherence to the Mediterranean diet is "poor" and "needs improvement".
The study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c > 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with "poor" and "need improvement" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26.
Read more
The findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected.
This study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.
Read the detailed description
Type 1 diabetes is an autoimmune disease that primarily occurs in childhood and is characterized by insufficient insulin secretion due to damage to the beta cells of the pancreas. While the incidence of Type 1 diabetes is increasing, the age of onset is also decreasing.
Diabetes management is crucial for maintaining and protecting health. When glycemic control is not achieved, the number of hypoglycemic and hyperglycemic events increases. HbA1c levels rise. This situation results in poor metabolic control. Oxidative stress in the body increases. Oxidative stress can play a role in the pathogenesis of diabetes, and if the disease is not controlled, it leads to the development and rapid progression of complications (retinopathy, nephropathy, neuropathy, etc.).
Many studies conducted on diabetic children have shown that their oxidative stress levels are high and antioxidant levels are low compared to healthy controls.
Nutrition, the foods we consume, are modifiable determinants of oxidative stress. The antioxidant and polyphenol content of the diet is particularly important. The Mediterranean diet; Foods rich in antioxidants, such as vegetables, fruits, legumes, fish, olive oil, nuts, and fermented foods, have been shown in many studies to have a protective effect.
In the first phase of the study, participants will be divided into two groups based on their HbA1c levels: those with HbA1c ≤7 (meeting the metabolic target) (Group A); and those with HbA1c >7 (not meeting the metabolic target) (Group B). Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing a Personal Information Form, a Biochemical Parameters Form, a 3-Day Food Intake Record, the KIDMED scale, and a continuous glucose monitoring sensor data form. Disease-specific information will be obtained from patient files, while biochemical data will include routine follow-up measurements such as complete blood count, CRP, CK, HbA1c%, lipid profile (HDL, LDL, total cholesterol, triglycerides), liver function tests (AST, ALT), kidney function tests (BUN, urea, creatinine), TSH, ST4, and vitamin D. Oxidative stress markers FASN, G6PD, GST, GR, and 6-PGD will be measured in venous blood. Blood samples will be taken in the outpatient clinic by a diabetes nurse. Anthropometric measurements will be taken as part of the personal information form. Body weight and height measurements will be taken in the outpatient clinic by a nutritionist (the same person). Height measurements will be taken with a stadiometer with 0.1 cm accuracy, while the patient is in an upright position with the head in the Frankfort plane (the ear canal and the lower boundary of the orbit/eye socket are aligned, and the gaze is parallel to the ground). Body weight measurements will be taken with a scale with 0.1 gram accuracy. Anthropometric data (body mass index, weight, height, and standard deviation scores) will be evaluated according to the standards developed by Neyzi et al. for Turkish children. To ensure accurate food consumption records, the nutritionist will provide training on correctly expressing portion sizes using spoons, bowls, ladles, cups, etc., and the patients will be asked to keep a record using a form for 2 weekdays and 1 weekend. In the evaluation of three-day food consumption, the Nutrition Information System (BEBIS) software package containing food compositions specific to Turkey will be used, and the analysis results will be compared with the dietary reference intakes in the recommendations of the Turkish Nutrition Guide.
In the second stage, the intervention group will be determined according to the results of the KIDMED (Mediterranean Diet Quality) scale, which is a pediatric Mediterranean diet adherence scale. The KIDMED scale (Mediterranean Diet Quality) was developed by Serra Majem et al. in 2004. The Turkish validity and reliability study of the scale was conducted by Şahingöz et al. in 2019. The scale consists of 16 questions. The questions are answered with yes (1) and no (2). Items 6, 12, 14, and 16 are scored as -1, and the remaining 12 items are scored as +1. In the evaluation of the scale, ≤ 3 is considered low adherence, 4-7 is considered moderate adherence, and ≥ 8 is considered high adherence. In our study, those in Group B who did not meet metabolic targets, and those with KIDMED results deemed "poor" and "needing improvement," will form the intervention group (Group C).
Adolescents in Group C will be scheduled for a 12-week Mediterranean diet intervention. The Mediterranean Diet training is planned as a 30-45 minute face-to-face meeting, and the brochure to be used in the training is available in Appendix 1. Visits will be made by phone between weeks 2-3 and weeks 7-9, and diet compliance will be monitored with dietitian consultations, with additional motivational consultations provided if necessary. A face-to-face meeting will be held in week 12, and anthropometric measurements will be repeated. Three-day food consumption records will be taken. Biochemical data obtained during routine 3-month follow-up will be retrieved from file information. Oxidative stress markers will be repeated.
If there are cases in Group A that are poor or needing improvement, these individuals will also receive Mediterranean Diet training, and their follow-up will continue with the dietitian of the department they are being monitored by. Participants in group B who received a 'good' KIDMED score will continue with standard medical nutritional therapy under the guidance of a dietitian.
- Being tested
- Mediterranean Diet Intervention
- Keywords
- Type 1 Diabetes, Mediterranean Diet, Oxidative Stress
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet InterventionBehavioural
Participants will follow a Mediterranean diet rich in plant-based foods, olive oil as the main fat source, moderate consumption of fish and dairy products, and limited intake of red and processed meats. Dietary adherence will be assessed using food records, and participants will be monitored throughout the study period to ensure compliance.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Group | Experimental | Participants will follow a Mediterranean diet during the 12-week follow-up period. Adherence to the diet will be monitored. Receives: Behavioral: Mediterranean Diet Intervention |
| Control Group | No intervention | Participants in the control group will not receive any dietary intervention. Baseline clinical and biochemical measurements will be obtained, and participants will continue their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c
Measured: 12 weeks compared to baseline
Mediterranean Diet Quality (KIDMED) Scale
Mediterranean Diet Quality (KIDMED) Score: Accordingly, the scores derived from the checklist are classified into three categories: low adherence (≤3), moderate adherence (4-7), and high adherence (≥8).
Measured: 12 weeks compared to baseline
6-PGD
6-phosphogluconate dehydrogenase
Measured: 12 weeks compared to baseline
GR
U/L, glutathione reductase
Measured: 12 weeks compared to baseline
GST
glutathione S-transferase
Measured: 12 weeks compared to baseline
G6PD
glucose-6-phosphate dehydrogenase
Measured: 12 weeks compared to baseline
FASN
ng/mL, fatty acid synthase
Measured: 12 weeks compared to baseline
Secondary outcomes (52)
Vitamin D
vitamin D
Measured: 12 weeks compared to baseline
TSH
Thyroid stimulated hormone
Measured: 12 weeks compared to baseline
ST4
serum free thyroxine
Measured: 12 weeks compared to baseline
CRP
mg/L, C-Reactive Protein
Measured: 12 weeks compared to baseline
CK
U/L, Creatine Kinase
Measured: 12 weeks compared to baseline
Total Cholesterol
Serum Total Cholesterol
Measured: 12 weeks compared to baseline
LDL-C
mg/dl, LDL cholesterol
Measured: 12 weeks compared to baseline
HDL-C
mg/dl, HDL cholesterol
Measured: 12 weeks compared to baseline
Triglycerides
mg/dL
Measured: 12 weeks compared to baseline
ALT
U/L, Alanine Aminotransferase
Measured: 12 weeks compared to baseline
AST
U/L, Aspartate Aminotransferase
Measured: 12 weeks compared to baseline
BUN
mg/dL, Blood Urea Nitrogen
Measured: 12 weeks compared to baseline
Creatinine
mg/dL
Measured: 12 weeks compared to baseline
Fasting Plasma Glucose
FPG mg/dl
Measured: 12 weeks compared to baseline
Weight
Body weight, kg
Measured: 12 weeks compared to baseline
Body Mass Index
BMI kg/m2
Measured: 12 weeks compared to baseline
Carbohydrate
Carbohydrate intake, gram
Measured: 12 weeks compared to baseline
Carbohydrate
Carbohydrate intake, %
Measured: 12 weeks compared to baseline
Protein
Protein intake, gram
Measured: 12 weeks compared to baseline
Protein
Protein intake, %
Measured: 12 weeks compared to baseline
Fat
Fat intake, gram
Measured: 12 weeks compared to baseline
Fat
Fat intake, %
Measured: 12 weeks compared to baseline
Energy
Energy intake, kcal
Measured: 12 weeks compared to baseline
Dietary Fiber
Dietary Fiber intake, gram
Measured: 12 weeks compared to baseline
TIR
Time in Range (%70-180 mg/dL), CGM metric
Measured: 12 weeks compared to baseline
TAR
Time Above Range (%181-250), CGM metric
Measured: 12 weeks compared to baseline
TAR
Time Above Range (% >250 mg/dL), CGM metric
Measured: 12 weeks compared to baseline
TBR
Time Below Range (%54-69 mg/dL), CGM metric
Measured: 12 weeks compared to baseline
TBR
Time Below Range (%<54 mg/dL), CGM metric
Measured: 12 weeks compared to baseline
CV
Coefficient of Variation (%), CGM metric
Measured: 12 weeks compared to baseline
SD
Standard Deviation (mg/dL), CGM metric
Measured: 12 weeks compared to baseline
Mean Glucose Levels
mg/dL, CGM metric
Measured: 12 weeks compared to baseline
GMI
Glucose Management Indicator (%), CGM metric
Measured: 12 weeks compared to baseline
Nighttime TIR
Nighttime Time in Range (%), CGM metric
Measured: 12 weeks compared to baseline
Dietary Cholesterol
Dietary Cholesterol intake, mg
Measured: 12 weeks compared to baseline
Vitamin A
Vitamin A intake, µg
Measured: 12 weeks compared to baseline
Vitamin E
Vitamin E inatke, mg
Measured: 12 weeks compared to baseline
Vitamin B1
Vitamin B1 intake, mg
Measured: 12 weeks compared to baseline
Vitamin B2
Vitamin B2 intake, mg
Measured: 12 weeks compared to baseline
Vitamin B3
Vitamin B3 intake, mg
Measured: 12 weeks compared to baseline
Vitamin B5
Vitami B5 intake, mg
Measured: 12 weeks compared to baseline
Vitamin B6
Vitamin B6 intake, mg
Measured: 12 weeks compared to baseline
Vitamin B12
Vitamin B12 intake, µg
Measured: 12 weeks compared to baseline
Folate
Folate intake, µg
Measured: 12 weeks compared to baseline
Vitamin C
Vitamin C intake, mg
Measured: 12 weeks compared to baseline
Calcium
Calcium İntake, mg
Measured: 12 weeks compared to baseline
Magnesium
Magnesium intake,mg
Measured: 12 weeks compared to baseline
Potassium
Potassium intake, mg
Measured: 12 weeks compared to baseline
Phosphorus
Phosphorus intake, mg
Measured: 12 weeks compared to baseline
Iron (Fe)
Iron intake, mg
Measured: 12 weeks compared to baseline
Zinc
Zinc intake, mg
Measured: 12 weeks compared to baseline
Height
Body Height, cm
Measured: 12 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (Juvenile Onset)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Before-after, prospective
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Eliuz Tipici, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544368
- Sponsor's protocol ID
- 42770
- Acronym
- MEDOX-T1D
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Adherence to the Mediterranean Diet and Oxidative Stress in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07544368
- Acronym / sponsor ID
- MEDOX-T1D / 42770
- Keywords
- Type 1 Diabetes, Mediterranean Diet, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c > 7%) and whose adherence to the Mediterranean diet is "poor" and "needs improvement".
The study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c > 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with "poor" and "need improvement" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26.
The findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected.
This study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.
Detailed description
Type 1 diabetes is an autoimmune disease that primarily occurs in childhood and is characterized by insufficient insulin secretion due to damage to the beta cells of the pancreas. While the incidence of Type 1 diabetes is increasing, the age of onset is also decreasing.
Diabetes management is crucial for maintaining and protecting health. When glycemic control is not achieved, the number of hypoglycemic and hyperglycemic events increases. HbA1c levels rise. This situation results in poor metabolic control. Oxidative stress in the body increases. Oxidative stress can play a role in the pathogenesis of diabetes, and if the disease is not controlled, it leads to the development and rapid progression of complications (retinopathy, nephropathy, neuropathy, etc.).
Many studies conducted on diabetic children have shown that their oxidative stress levels are high and antioxidant levels are low compared to healthy controls.
Nutrition, the foods we consume, are modifiable determinants of oxidative stress. The antioxidant and polyphenol content of the diet is particularly important. The Mediterranean diet; Foods rich in antioxidants, such as vegetables, fruits, legumes, fish, olive oil, nuts, and fermented foods, have been shown in many studies to have a protective effect.
In the first phase of the study, participants will be divided into two groups based on their HbA1c levels: those with HbA1c ≤7 (meeting the metabolic target) (Group A); and those with HbA1c >7 (not meeting the metabolic target) (Group B). Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing a Personal Information Form, a Biochemical Parameters Form, a 3-Day Food Intake Record, the KIDMED scale, and a continuous glucose monitoring sensor data form. Disease-specific information will be obtained from patient files, while biochemical data will include routine follow-up measurements such as complete blood count, CRP, CK, HbA1c%, lipid profile (HDL, LDL, total cholesterol, triglycerides), liver function tests (AST, ALT), kidney function tests (BUN, urea, creatinine), TSH, ST4, and vitamin D. Oxidative stress markers FASN, G6PD, GST, GR, and 6-PGD will be measured in venous blood. Blood samples will be taken in the outpatient clinic by a diabetes nurse. Anthropometric measurements will be taken as part of the personal information form. Body weight and height measurements will be taken in the outpatient clinic by a nutritionist (the same person). Height measurements will be taken with a stadiometer with 0.1 cm accuracy, while the patient is in an upright position with the head in the Frankfort plane (the ear canal and the lower boundary of the orbit/eye socket are aligned, and the gaze is parallel to the ground). Body weight measurements will be taken with a scale with 0.1 gram accuracy. Anthropometric data (body mass index, weight, height, and standard deviation scores) will be evaluated according to the standards developed by Neyzi et al. for Turkish children. To ensure accurate food consumption records, the nutritionist will provide training on correctly expressing portion sizes using spoons, bowls, ladles, cups, etc., and the patients will be asked to keep a record using a form for 2 weekdays and 1 weekend. In the evaluation of three-day food consumption, the Nutrition Information System (BEBIS) software package containing food compositions specific to Turkey will be used, and the analysis results will be compared with the dietary reference intakes in the recommendations of the Turkish Nutrition Guide.
In the second stage, the intervention group will be determined according to the results of the KIDMED (Mediterranean Diet Quality) scale, which is a pediatric Mediterranean diet adherence scale. The KIDMED scale (Mediterranean Diet Quality) was developed by Serra Majem et al. in 2004. The Turkish validity and reliability study of the scale was conducted by Şahingöz et al. in 2019. The scale consists of 16 questions. The questions are answered with yes (1) and no (2). Items 6, 12, 14, and 16 are scored as -1, and the remaining 12 items are scored as +1. In the evaluation of the scale, ≤ 3 is considered low adherence, 4-7 is considered moderate adherence, and ≥ 8 is considered high adherence. In our study, those in Group B who did not meet metabolic targets, and those with KIDMED results deemed "poor" and "needing improvement," will form the intervention group (Group C).
Adolescents in Group C will be scheduled for a 12-week Mediterranean diet intervention. The Mediterranean Diet training is planned as a 30-45 minute face-to-face meeting, and the brochure to be used in the training is available in Appendix 1. Visits will be made by phone between weeks 2-3 and weeks 7-9, and diet compliance will be monitored with dietitian consultations, with additional motivational consultations provided if necessary. A face-to-face meeting will be held in week 12, and anthropometric measurements will be repeated. Three-day food consumption records will be taken. Biochemical data obtained during routine 3-month follow-up will be retrieved from file information. Oxidative stress markers will be repeated.
If there are cases in Group A that are poor or needing improvement, these individuals will also receive Mediterranean Diet training, and their follow-up will continue with the dietitian of the department they are being monitored by. Participants in group B who received a 'good' KIDMED score will continue with standard medical nutritional therapy under the guidance of a dietitian.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Before-after, prospective
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Group | Experimental | Behavioral: Mediterranean Diet InterventionParticipants will follow a Mediterranean diet during the 12-week follow-up period. Adherence to the diet will be monitored. |
| Control Group | No intervention | –Participants in the control group will not receive any dietary intervention. Baseline clinical and biochemical measurements will be obtained, and participants will continue their usual care. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ages 10-18 years
- BMI between the 5th and 95th percentile (normal to overweight)
- Diagnosis of Type 1 Diabetes for ≥1.5 years
- Users of a continuous glucose monitoring (CGM) system
- No other comorbidities and not taking medications
Key exclusion criteria (5 listed)
- Presence of any acute or chronic disease other than Type 1 Diabetes
- Current use of any medications
- BMI ≥ 95th percentile (obese)
- Presence of an eating disorder
- Use of tobacco, e-cigarettes, or alcohol
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 |
|---|---|---|
| Mediterranean Diet InterventionParticipants will follow a Mediterranean diet rich in plant-based foods, olive oil as the main fat source, moderate consumption of fish and dairy products, and limited intake of red and processed meats. Dietary adherence will be assessed using food records, and participants will be monitored throughout the study period to ensure compliance. | Behavioural | Mediterranean Diet Group |
Primary outcome
HbA1c
Time frame: 12 weeks compared to baseline
HbA1c
Mediterranean Diet Quality (KIDMED) Scale
Time frame: 12 weeks compared to baseline
Mediterranean Diet Quality (KIDMED) Score: Accordingly, the scores derived from the checklist are classified into three categories: low adherence (≤3), moderate adherence (4-7), and high adherence (≥8).
6-PGD
Time frame: 12 weeks compared to baseline
6-phosphogluconate dehydrogenase
GR
Time frame: 12 weeks compared to baseline
U/L, glutathione reductase
GST
Time frame: 12 weeks compared to baseline
glutathione S-transferase
G6PD
Time frame: 12 weeks compared to baseline
glucose-6-phosphate dehydrogenase
FASN
Time frame: 12 weeks compared to baseline
ng/mL, fatty acid synthase
52 secondary outcomes
Vitamin D
Time frame: 12 weeks compared to baseline
TSH
Time frame: 12 weeks compared to baseline
ST4
Time frame: 12 weeks compared to baseline
CRP
Time frame: 12 weeks compared to baseline
CK
Time frame: 12 weeks compared to baseline
Total Cholesterol
Time frame: 12 weeks compared to baseline
LDL-C
Time frame: 12 weeks compared to baseline
HDL-C
Time frame: 12 weeks compared to baseline
Triglycerides
Time frame: 12 weeks compared to baseline
ALT
Time frame: 12 weeks compared to baseline
AST
Time frame: 12 weeks compared to baseline
BUN
Time frame: 12 weeks compared to baseline
Creatinine
Time frame: 12 weeks compared to baseline
Fasting Plasma Glucose
Time frame: 12 weeks compared to baseline
Weight
Time frame: 12 weeks compared to baseline
Body Mass Index
Time frame: 12 weeks compared to baseline
Carbohydrate
Time frame: 12 weeks compared to baseline
Carbohydrate
Time frame: 12 weeks compared to baseline
Protein
Time frame: 12 weeks compared to baseline
Protein
Time frame: 12 weeks compared to baseline
Fat
Time frame: 12 weeks compared to baseline
Fat
Time frame: 12 weeks compared to baseline
Energy
Time frame: 12 weeks compared to baseline
Dietary Fiber
Time frame: 12 weeks compared to baseline
TIR
Time frame: 12 weeks compared to baseline
TAR
Time frame: 12 weeks compared to baseline
TAR
Time frame: 12 weeks compared to baseline
TBR
Time frame: 12 weeks compared to baseline
TBR
Time frame: 12 weeks compared to baseline
CV
Time frame: 12 weeks compared to baseline
SD
Time frame: 12 weeks compared to baseline
Mean Glucose Levels
Time frame: 12 weeks compared to baseline
GMI
Time frame: 12 weeks compared to baseline
Nighttime TIR
Time frame: 12 weeks compared to baseline
Dietary Cholesterol
Time frame: 12 weeks compared to baseline
Vitamin A
Time frame: 12 weeks compared to baseline
Vitamin E
Time frame: 12 weeks compared to baseline
Vitamin B1
Time frame: 12 weeks compared to baseline
Vitamin B2
Time frame: 12 weeks compared to baseline
Vitamin B3
Time frame: 12 weeks compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Intervention in people with Type 1 Diabetes (Juvenile Onset) and Continuous Glucose Monitoring System, run by Istanbul University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyza Eliuz Tipici (+90 554 624 57 68, beliuz@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks compared to baseline). The study lists 7 primary outcomes in all. 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 29 Apr 2026.