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NCT Number: NCT07673523

Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

Diabetes is a chronic metabolic disease in which nutrients such as carbohydrates, fats and proteins cannot be utilized sufficiently due to the inability to produce insulin or defects in the effect of the produced insulin. The risk of individuals encountering complications related to diabetes decreases when glycemic control is achieved in these patients. Therefore, nutrition is an necessary component of treatment. Although there are many studies in the literature examining the effect of carbohydrate intake on glycemic control in individuals with diabetes and monitoring carbohydrate intake in individuals with diabetes is the basic strategy for reaching glucose targets, a common denominator has not yet been reached for the optimal amount of carbohydrate intake for individuals with diabetes. There are a wide range of definitions regarding carbohydrate intake and studies on carbohydrate restriction, especially in individuals with Type 1 diabetes, are limited.

In present randomized controlled crossover study, three isocaloric different dietary treatment are planned to applied for 2 weeks in which (i) 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carbohydrates according to the individual characteristics of the patients, (ii) 50-55% of the daily energy requirement is provided from carbohydrates and (iii) carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supplementing 2 sachets (1 sachet 3.68 g inulin + 3.68 g ) where 50-55% of daily energy requirement is provided from carbohydrates together with fructooligosaccharide (FOS)) inulin fructooligosaccharide (FOS) supplementation. A 2-week washout period is planned between each diet model. The research will be conducted with 20 individuals with Type 1 diabetes using a Continuous Glucose Monitoring device. The proposed project aims to investigate the effect of different dietary treatments on glycemic control in individuals with Type 1 diabetes by using a continuous glucose measuring device. At the end of each dietary treatment application, the data obtained from the Continuous Glucose Measuring Device will be evaluated as the primary outcomes; total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose will be evaluated as the secondary outcomes. As a result of the research, the potential effects of different dietary treatments on glycemic control will be evaluated and the development of the most appropriate diet model for these patients will be contributed. In addition, this research will contribute to the improvement of the continuous glucose monitoring device.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 18-65 years diagnosed with Type 1 diabetes and currently using a Continuous Glucose Monitoring device

Exclusion criteria

  • Individuals with type 2 diabetes
  • Individuals with gestational diabetes
  • Breastfeeding individuals
  • Individuals with celiac disease
  • Individuals with gastroparesis
  • Renal insufficiency (tGFR ≤ 60 ml/min/1.73 m2)
  • Diagnosed liver failure
  • Immunodeficiency
  • Individuals with malignancy
  • Using nutritional supplements that may affect metabolic parameters

Treatment and study plan

fructooligosaccharide and inulin

Dietary Supplement

Carbohydrate content of diet

Dietary carbohydrate 30%

Other

Dietary carbohydrate is 30% of daily energy requirements

Dietary carbohydrate 50-55%

Other

Dietary carbohydrate is 50-55% of daily energy requirements

Primary outcomes

  1. Continuous Glucose Measuring Device Measurements

    Time frame: From the enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Other measurements

    Time frame: From the enrollment to the end of the treatment at 12 weeks

    total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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