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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Mediterranean Diet Intervention
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.

Beyza Eliuz Tipici contact

+90 554 624 57 68

beliuz@istanbul.edu.tr

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 groups in NCT07544368
Study groupRoleWhat they receive
Mediterranean Diet GroupExperimentalParticipants 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 GroupNo interventionParticipants 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.

  1. HbA1c

    HbA1c

    Measured: 12 weeks compared to baseline

  2. 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

  3. 6-PGD

    6-phosphogluconate dehydrogenase

    Measured: 12 weeks compared to baseline

  4. GR

    U/L, glutathione reductase

    Measured: 12 weeks compared to baseline

  5. GST

    glutathione S-transferase

    Measured: 12 weeks compared to baseline

  6. G6PD

    glucose-6-phosphate dehydrogenase

    Measured: 12 weeks compared to baseline

  7. FASN

    ng/mL, fatty acid synthase

    Measured: 12 weeks compared to baseline

Secondary outcomes (52)
  1. Vitamin D

    vitamin D

    Measured: 12 weeks compared to baseline

  2. TSH

    Thyroid stimulated hormone

    Measured: 12 weeks compared to baseline

  3. ST4

    serum free thyroxine

    Measured: 12 weeks compared to baseline

  4. CRP

    mg/L, C-Reactive Protein

    Measured: 12 weeks compared to baseline

  5. CK

    U/L, Creatine Kinase

    Measured: 12 weeks compared to baseline

  6. Total Cholesterol

    Serum Total Cholesterol

    Measured: 12 weeks compared to baseline

  7. LDL-C

    mg/dl, LDL cholesterol

    Measured: 12 weeks compared to baseline

  8. HDL-C

    mg/dl, HDL cholesterol

    Measured: 12 weeks compared to baseline

  9. Triglycerides

    mg/dL

    Measured: 12 weeks compared to baseline

  10. ALT

    U/L, Alanine Aminotransferase

    Measured: 12 weeks compared to baseline

  11. AST

    U/L, Aspartate Aminotransferase

    Measured: 12 weeks compared to baseline

  12. BUN

    mg/dL, Blood Urea Nitrogen

    Measured: 12 weeks compared to baseline

  13. Creatinine

    mg/dL

    Measured: 12 weeks compared to baseline

  14. Fasting Plasma Glucose

    FPG mg/dl

    Measured: 12 weeks compared to baseline

  15. Weight

    Body weight, kg

    Measured: 12 weeks compared to baseline

  16. Body Mass Index

    BMI kg/m2

    Measured: 12 weeks compared to baseline

  17. Carbohydrate

    Carbohydrate intake, gram

    Measured: 12 weeks compared to baseline

  18. Carbohydrate

    Carbohydrate intake, %

    Measured: 12 weeks compared to baseline

  19. Protein

    Protein intake, gram

    Measured: 12 weeks compared to baseline

  20. Protein

    Protein intake, %

    Measured: 12 weeks compared to baseline

  21. Fat

    Fat intake, gram

    Measured: 12 weeks compared to baseline

  22. Fat

    Fat intake, %

    Measured: 12 weeks compared to baseline

  23. Energy

    Energy intake, kcal

    Measured: 12 weeks compared to baseline

  24. Dietary Fiber

    Dietary Fiber intake, gram

    Measured: 12 weeks compared to baseline

  25. TIR

    Time in Range (%70-180 mg/dL), CGM metric

    Measured: 12 weeks compared to baseline

  26. TAR

    Time Above Range (%181-250), CGM metric

    Measured: 12 weeks compared to baseline

  27. TAR

    Time Above Range (% >250 mg/dL), CGM metric

    Measured: 12 weeks compared to baseline

  28. TBR

    Time Below Range (%54-69 mg/dL), CGM metric

    Measured: 12 weeks compared to baseline

  29. TBR

    Time Below Range (%<54 mg/dL), CGM metric

    Measured: 12 weeks compared to baseline

  30. CV

    Coefficient of Variation (%), CGM metric

    Measured: 12 weeks compared to baseline

  31. SD

    Standard Deviation (mg/dL), CGM metric

    Measured: 12 weeks compared to baseline

  32. Mean Glucose Levels

    mg/dL, CGM metric

    Measured: 12 weeks compared to baseline

  33. GMI

    Glucose Management Indicator (%), CGM metric

    Measured: 12 weeks compared to baseline

  34. Nighttime TIR

    Nighttime Time in Range (%), CGM metric

    Measured: 12 weeks compared to baseline

  35. Dietary Cholesterol

    Dietary Cholesterol intake, mg

    Measured: 12 weeks compared to baseline

  36. Vitamin A

    Vitamin A intake, µg

    Measured: 12 weeks compared to baseline

  37. Vitamin E

    Vitamin E inatke, mg

    Measured: 12 weeks compared to baseline

  38. Vitamin B1

    Vitamin B1 intake, mg

    Measured: 12 weeks compared to baseline

  39. Vitamin B2

    Vitamin B2 intake, mg

    Measured: 12 weeks compared to baseline

  40. Vitamin B3

    Vitamin B3 intake, mg

    Measured: 12 weeks compared to baseline

  41. Vitamin B5

    Vitami B5 intake, mg

    Measured: 12 weeks compared to baseline

  42. Vitamin B6

    Vitamin B6 intake, mg

    Measured: 12 weeks compared to baseline

  43. Vitamin B12

    Vitamin B12 intake, µg

    Measured: 12 weeks compared to baseline

  44. Folate

    Folate intake, µg

    Measured: 12 weeks compared to baseline

  45. Vitamin C

    Vitamin C intake, mg

    Measured: 12 weeks compared to baseline

  46. Calcium

    Calcium İntake, mg

    Measured: 12 weeks compared to baseline

  47. Magnesium

    Magnesium intake,mg

    Measured: 12 weeks compared to baseline

  48. Potassium

    Potassium intake, mg

    Measured: 12 weeks compared to baseline

  49. Phosphorus

    Phosphorus intake, mg

    Measured: 12 weeks compared to baseline

  50. Iron (Fe)

    Iron intake, mg

    Measured: 12 weeks compared to baseline

  51. Zinc

    Zinc intake, mg

    Measured: 12 weeks compared to baseline

  52. 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.

  1. First posted22 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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)
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

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.

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