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.

NCT Number	NCT07673523
Lead Sponsor	Hacettepe University
Conditions	Type 1 Diabetes Mellitus
Enrollment	30 participants
Start Date	2026-05-11
Primary Completion	2026-07-20 (estimated)
Study Completion	2026-07-27 (estimated)
Updated on ClinicalTrials.gov	2026-06-29